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

Model Number N/A

Device Problems Circuit Failure (1089); Failure to Sense (1559)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

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.The getinge field service engineer (fse) performing repairs reassembled the monitor but the issue persisted.The fse replaced the touchscreen to correct the issue, then completed testing.Unrelated to the reported issue and in order to carry out a months worth of testing, the fse also replaced the safety disk and tidal disk the performed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).

Event Description

It was reported that during repair of the cardiosave intra-aortic balloon pump (iabp), the touch panel failed at the final check prior to returning the iabp unit to use.It was noted that the area around start key is reacting.Since the possible cause of this issue has not been determined yet, the monitor will be re-assembled.If the issue is not resolved by assembly of the monitor, the touch panel will be required to be replaced.There was no patient involved an no adverse event was reported.

Event Description

It was reported that during repair of the cardiosave intra-aortic balloon pump (iabp), the touch panel failed at the final check prior to returning the iabp unit to use.It was noted that the area around start key is reacting.Since the possible cause of this issue has not been determined yet, the monitor will be re-assembled.If the issue is not resolved by assembly of the monitor, the touch panel will be required to be replaced.There was no patient involved an no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYBE 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: 9166878
• MDR Text Key: 189505798
• Report Number: 2249723-2019-01613
• Device Sequence Number: 1
• Product Code: DSP
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1