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

Model Number N/A

Device Problem Device Sensing Problem (2917)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge service territory manager (stm) was dispatched to evaluate the iabp and was not able to reproduce the reported issue.The stm troubleshot, tested with the simulator tested all trigger sources, different rates, different wave settings, and find an issue triggering the source on ecg, pressure, or a or av.The stm completed autofill, on auto and semi auto without issue.The unit passed all functional, and safety checks to factory specifications.The unit was returned to customer and cleared for clinical use.

Event Description

It was reported by the customer that the cardiosave intra-aortic balloon pump (iabp) does not trigger when pumping.It is unknown under which circumstances this occurred; however there was no harm or injury to patient and no adverse event was reported.

Event Description

It was reported by the customer that the cardiosave intra-aortic balloon pump (iabp) does not trigger when pumping.It is unknown under which circumstances this occurred; however there was no harm or injury to patient 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: 9966997
• MDR Text Key: 190937986
• Report Number: 2249723-2020-00624
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

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: 03/24/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1