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

Model Number N/A

Device Problems Inability to Auto-Fill (1044); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed 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) was dispatched to evaluate the iabp and was able to confirm the reported issue.The stm found that the iabp was not maintaining vacuum during cycling.To address the issue the stm replaced the pneumatic interface module and calibrated; the stm performed all functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) will not fill or calibrate.It is unknown under which circumstances this event occurred; however there was no patient involvement and no adverse event reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) will not fill or calibrate.It is unknown under which circumstances this event occurred; however there was no patient involvement and no adverse event 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: 10201611
• MDR Text Key: 196750561
• Report Number: 2249723-2020-00986
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1