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

Model Number N/A

Device Problem Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The stm evaluated the iabp unit and removed the side panel and fixed the power cord jam.The fse verified that the iabp unit was now fully functional.

Event Description

It was reported that upon transfer of the cardiosave intra-aortic balloon pump (iabp) from one storage space to another, it was observed that the power cable was jammed.The power cable had been unplugged and reeled in and when the customer attempted to plug the power cable back in, the cable jammed.It was later noted that the iabp unit could not be used unless it was ran on battery power as the cable did not reach the socket.There was no patient involved and no adverse event was reported.

Event Description

It was reported that upon transfer of the cardiosave intra-aortic balloon pump (iabp) from one storage space to another, it was observed that the power cable was jammed.The power cable had been unplugged and reeled in and when the customer attempted to plug the power cable back in, the cable jammed.It was later noted that the iabp unit could not be used unless it was ran on battery power as the cable did not reach the socket.There was no patient involved and no adverse event was 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: 10408589
• MDR Text Key: 203118354
• Report Number: 2249723-2020-01278
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• 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: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1