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

Model Number N/A

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2019

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.A supplemental report will be submitted when additional information is provided.(b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) displayed a "red triangle with an exclamation point" for battery bay 2 even though the batteries showed an adequate charge.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) displayed a "red triangle with an exclamation point" for battery bay 2 even though the batteries showed an adequate charge.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, d10, g4, g7, h2, h3, h6, h10.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.There was a loose wire, so the fse reconnected it and the battery charged as expected.The fse 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.

• 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: 9520842
• MDR Text Key: 191405215
• Report Number: 2249723-2019-02083
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1