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

Model Number N/A

Device Problems No Device Output (1435); Failure to Sense (1559)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2019

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 getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm was able to verify the reported alarm in the iabp's diagnostic error log.This error is indicative of a fiber optic module issue and the alarm log showed the error was a three minute process.The stm removed all the boards in the pcb cage and reseated them.The stm then completed all diagnostic and performance tests and could not duplicate any issues.The stm ran the fiber optic test several times and could not duplicate the errors.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) kept alarming "fos continuous bit failure" and that the printer was not printing.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) kept alarming "fos continuous bit failure" and that the printer was not printing.It is unknown under which circumstances this event occurred; however there was no patient involvement and no adverse event reported.

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm was able to verify the reported alarm in the iabp's diagnostic error log.This error is indicative of a fiber optic module issue and the alarm log showed the error was a three minute process.The stm removed all the boards in the pcb cage and reseated them.The stm then completed all diagnostic and performance tests and could not duplicate any issues.The stm ran the fiber optic test several times and could not duplicate the errors.In addition, the stm inspected the printer and did not find any problems.All functional and safety tests were passed to meet factory specifications, and the iabp was returned 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: 8621859
• MDR Text Key: 145503845
• Report Number: 2249723-2019-00825
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• 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
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1