MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-0800-53

Device Problems Mechanical Problem (1384); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm confirmed the issue.An adjustment was made to the release handle as it was not returning to its normal position to accept the console when returned to the part.The stm completed all safety, functionality, calibration checks, and all tests passed to factory specifications.The iabp unit was cleared for clinical use, and released to the customer.

Event Description

It was reported during training by a getinge clinical representative that the cardiosave intra-aortic balloon pump (iabp) locking mechanism on the cart was not functioning properly, and the batteries would not charge.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b3, b4, b5, d5, e1(initial reporter), e2, e3, g3, g4, g7, h2, h6(evaluation method codes & device codes), h10, h11.Corrected fields: g3, h6(evaluation conclusion code), h10.The correct date received by mfg(g4) that should have been reported in the initial report is 17-sep-2020.The initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported issue were noted.A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm confirmed the issue.An adjustment was made to the release handle as it was not returning to its normal position to accept the console when returned to the cart.The stm then performed and completed a preventive maintenance (pm) with all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during training performed by a getinge clinical representative, the cardiosave intra-aortic balloon pump (iabp) locking mechanism on the cart was not functioning properly and the batteries would not charge.The release handle to detach the iabp in transport/rescue mode was sticking and the console would not latch or connect properly.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10641285
• MDR Text Key: 210178739
• Report Number: 2249723-2020-01636
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1