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

Model Number 0998-00-0800-53

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

It was reported that during preventative maintenance performed by a getinge field service engineer (gfse) the cardiosave intra aortic balloon pump (iabp) it was discovered that the iabp logs indicated there had been several code 137 errors.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device|10: during a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered several "fault # 137 (application level fault for code on the video (head) processor) " in the error log of the cardiosave intra-aortic balloon pump (iabp) unit over several days.To fix the issue, the fse replaced the pcba, video generator (0670-00-1182).Unrelated, the fse also replaced the primary 9v battery alkaline, and then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.The initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13689718
• MDR Text Key: 290171199
• Report Number: 2249723-2022-00473
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1