Maquet cardiosave recall

Author: rjna

August undefined, 2024

WebOct 29, 2024 · Reason for Recall Datascope/Getinge/Maquet is recalling this product due to the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting performance... WebOct 29, 2024 · Recalled Product. Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs. Product Codes and Lot Numbers: See Recall Database Entry. Devices Recalled in the United States: 137 battery ...

Manufacturer Datascope Cs100 Medwrench Join The Medical

WebDec 16, 2024 · Fluid leaks causing unexpected pump shutdown or the inability to initiate therapy have prompted the recall of Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs). At the time the recall was issued, the U.S. Food and Drug Administration (FDA) had received 71 complaints. One death was reported. These … WebDevice Recall Maquet Model / Serial HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786 ... Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Manufacturer Maquet … fidelis care handbook medicaid 2016

FDA Class I Recall: Cardiosave Hybrid and Cardiosave Rescue …

WebJul 11, 2024 · Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794. Code Information. Lot 70131093; UDI 04037691741543. Recalling Firm/. Manufacturer. Maquet Cardiovascular Us Sales, … WebDec 16, 2024 · Recalled Product Product Names: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Model Numbers: See Recall Database Entry Manufacturing... WebMaquet Cardiosave Rescue Features. The Maquet CARDIOSAVE Rescue represents a giant leap forward in functionality and versatility while continuing to deliver the performance and intuitiveness of the Datascope … fidelis care formation

Class 2 Device Recall Cardiosave Hybrid IntraAortic …

Device Recall Maquet - International Consortium of Investigative ...

WebJul 24, 2024 · Getinge is recalling numerous Maquet/Datascope intra-aortic balloon pumps (IABPs) due to potential battery failure during use that can lead to unexpected stopping and shortened run times. Maquet/Datascope has received reports of five patient deaths … WebMar 7, 2024 · The recall notice affects lithium-ion batteries used with its Cardiosave hybrid IABP and its Cardiosave rescue IABP with part number 0146-00-0097, distributed between Dec. 12, 2011 and Nov. 9, 2016. grey and yellow nike inflictsWebDec 22, 2024 · (UPDATED) The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been placed under recall by the manufacturer (Getinge/Datascope/Maquet) following reports of fluid leaks, the US Food and Drug Administration announced last Thursday. The agency deemed the action a Class I … fidelis care harp medicaid

"WebDec 17, 2024 · So far, 4,338 devices have been recalled in the U.S., with one death and 71 complaints related to the device issue, which the FDA confirmed is fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy, the regulatory body said. " - Maquet cardiosave recall

Maquet cardiosave recall

New Recall for Maquet/Datascope IABPs Due to Potential

WebNov 15, 2024 · Datascope/Getinge Technical Support. 888-943-8872. Manufacturer Reason. for Recall. Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability. WebDec 16, 2024 · FDA Announces Recall of Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue IABPs December 16, 2024—FDA advised that the Getinge Group has recalled the Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs; …

Did you know?

WebCARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP. Model / Serial PART NUMBER: 0146-00-0097 DISTRIBUTION DATE: All Li-Ion Batteries Distributed from December 12, 2011 to November 9, 2016 ... Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their … WebOct 29, 2024 · FDA announces serious device recall Oct 29, 2024 - 03:06 PM The Food and Drug Administration today announced a Class 1 recall of battery packs for an intra-aortic balloon pump used with patients undergoing surgery and to treat adults with acute coronary syndrome or heart failure complications.

WebJun 11, 2024 · On June 6, Maquet Datascope Corp. issued a Class I recall for the CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), a cardiac assist device used for patients undergoing cardiac and non-cardiac surgery and patients with acute coronary syndrome or complications from heart failure, due to a design issue that allows fluid … WebGetinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp.,...

WebDatascope Cs100 Service Manual iforex indicators com. Getinge s Maquet Datascope recall select IABPs over. China Bionet Cardiocare 2000 EKG Cable 10lead 15pins. Hospital Furniture Manufacturing Companies Hospital. Public tenders for Medical equipment in United States. Datascope MAQUET Intra Aortic Balloon Pump Recall ? Daily. WebWeb getinge group maquet cardiosave iabp quick reference manual (41 pages) iab insertion, iabp operation. Cardiosave hybrid retains the familiar look of datascope pumps, while offering an improved user interface and improved algorithms and pneumatics to allow for enhanced. ... Recall Datascope/Getinge Cardiosave Hybrid, Cardiosave Rescue, …

WebDevice Recall Maquet Model / Serial HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786 ...

WebIABP. CARDIOSAVE Hybrid retains the familiar look of Datascope pumps, while offering an improved user interface and improved algorithms and pneumatics to allow for enhanced therapy. CARDIOSAVE Hybrid easily and quickly converts from hospital configuration to transport configuration. FORUMS View All (14) fidelis care hempsteadWebMAQUET CARDIOSAVE hybrid and MAQUET CARDIOSAVE rescue Product Code/Part Number: 0998-XX-0800-XX Distributed Affected Lot Number: All Distribution Dates: Since March 6, 2012 ... This voluntary recall only affects the products listed on page 1; no other products are affected fidelis care headquarters addressWebMaquet Cardiovascular Us Sales, Llc QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Res... 1 11/28/2024 Maquet Cardiovascular Us Sales, Llc Cardiosave Hybrid IABP, Part Number 0998-00-0800-53: 1 10/27/2024 Maquet Datascope Corp - Cardiac Assist Division fidelis care holidaysWebSep 8, 2024 · Recall Status 1: Open 3, Classified: Recall Number: Z-0076-2024: Recall Event ID: 88651: 510(K)Number: K181122 Product Classification: System, balloon, intra-aortic and control - Product Code DSP:... fidelis care history grey and yellow quiltWebDec 21, 2015 · U kunt hier een specifiek type publicatie kiezen, zoals brochures of jaarverslagen. fidelis care hipaa formWebJun 7, 2024 · The US Food and Drug Administration (FDA) has alerted users of Datascope Corp/MAQUET’s Cardiosave hybrid intra-aortic balloon pump (IABP) to a “design issue” that enables fluids to leak into the device, classifying a recent field corrective action by the company as a Class I recall. “The fluid can cause corrosion of internal components ... grey and yellow persian carpets