MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Component Incompatible (1108)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not performed as the serial number for the unit was not identified.A supplemental report will be submitted when subsequent information is provided.

Event Description

It was reported that during field service corrective action (fsca) recall, the datasettes for the cs100 intra-aortic balloon pump (iabp) failed to work when installed.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

The aware date of the initial mdr was incorrectly reported.The initial mdr aware date should have read 04/10/2018 (10-apr-2018).The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) evaluated the iabp and was able to reproduce the reported issue.To resolve the issue, the stm replaced the datasettes.All functional and safety tests were passed to meet factory specifications and the iabp was returned to the customer and cleared for clinical service.The initial reporter named is a getinge designee who has different contact details from that of the event site; their contact information are as follows: (b)(6).

Event Description

It was reported that during field service corrective action (fsca) recall, the datasettes for the cs100 intra-aortic balloon pump (iabp) failed to work out of box (oob) when installed.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

The national repair center (nrc) received the failed parts for evaluation.A senior repair technician installed the iab datasettes into test fixture.The datassettes failed testing , verifying the reported failure.The nrc sent the datasettes to supplier for failure analysis.A supplemental report will be submitted when the evaluation has been completed.

Event Description

It was reported that during a field service corrective action (fsca) recall related to a software update that was performed by a getinge service territory manager (stm), the new datasettes for the cs100 intra-aortic balloon pump (iabp) failed to work when installed.This is an out of box (oob) failure.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

The getinge service territory manager (stm) that encountered the issue, replaced the oob datasettes with another set of new datasettes, and then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.The suspected faulty oob datasettes will be sent to getinge's national repair center (nrc) for evaluation.A supplemental report will be submitted upon completion of this investigation.Updated fields: b4, g4, g7, h2, h10, and h11.Corrected data: b5, d4 (catalog#), h10.

Event Description

It was reported that during a field service corrective action (fsca) recall related to a software update that was performed by a getinge service territory manager (stm), the new datasettes for the cs100 intra-aortic balloon pump (iabp) failed to work when installed.This is an out of box (oob) failure.There was no patient involvement, and no adverse event was reported.

Event Description

It was reported that during a field service corrective action (fsca) recall related to a software update that was performed by a getinge service territory manager (stm), the new datasettes for the cs100 intra-aortic balloon pump (iabp) failed to work when installed.This is an out of box (oob) failure.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

The supplier reported that they verified the reported failure.They stated u1 was defective and unable to reprogram.The supplier scrapped the defective dss datasette.However, the supplier returned the other datasette to the national repair center (nrc).The supplier verified the reported failure.They reprogrammed u1 and the datasette passed all of their testing.The national repair center installed the datasette into the main board of the cs100 test fixture and tested the datasette to factory specifications per procedure, and cs100 service manual, and the datasette passed testing.The datasette was scrapped and retained in the nrc per procedure.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8632113
• MDR Text Key: 145778272
• Report Number: 2249723-2019-00832
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 09/19/2019; 09/19/2019; 09/25/2019; 01/09/2020
• Supplement Dates FDA Received: 09/19/2019; 09/19/2019; 10/17/2019; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1