MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-0800-XX

Device Problem No Audible Alarm (1019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge fse replaced the backplane board to fix the issue, due to the speaker being mounted on the board.The iabp was cleared for clinical use.

Event Description

It was reported that during operation test before shipment, a company representative field service engineer (fse) found that when the cardiosave intra-aortic balloon pump (iabp) was powered-on, a beep sound was heard lower than usual.It was a speaker failure.This is an out of box (oob) issue.There was no patient harm and no adverse event was reported.

Manufacturer Narrative

The suspected defective backplane board was returned to getinge's national repair center (nrc) for failure analysis.A technician inspected the backplane board per procedure with no visual damage observed.The nrc installed the board into the cardiosave test fixture and tested the board to factory specifications per the cardiosave service manual.The nrc verified the failure of the beep sound being lower than normal when the unit was first turned on.The board failed testing and is being sent to the supplier for failure analysis per procedure.

Event Description

It was reported that during operation test before shipment, a company representative field service engineer (fse) found that when the cardiosave intra-aortic balloon pump (iabp) was powered-on, a beep sound was heard lower than usual.It was a speaker failure.This is an out of box (oob) issue.There was no patient harm and no adverse event was reported.

Manufacturer Narrative

The supplier returned the backplane board to the national repair center (nrc) and verified the failure.The supplier replaced the buzzer u2 and the board passed testing.A technician of the nrc inspected the board with no visual damage observed.The technician then installed the board into a cardiosave test fixture and tested the board to factory specifications per service bulletin, and the board passed testing.The board will be retained in the nrc per procedure.

Event Description

It was reported that during operation test before shipment, a company representative field service engineer (fse) found that when the cardiosave intra-aortic balloon pump (iabp) was powered-on, a beep sound was heard lower than usual.It was a speaker failure.This is an out of box (oob) issue.There was no patient harm and no adverse event was reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7735196
• MDR Text Key: 115597216
• Report Number: 2249723-2018-01272
• 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,Followup
• Report Date: 01/29/2019

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 Catalogue Number: 0998-00-0800-XX
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 10/08/2018; 01/08/2019
• Supplement Dates FDA Received: 11/02/2018; 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1