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

Model Number N/A

Device Problems Circuit Failure (1089); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided.The getinge fse replaced the video generator board.

Event Description

It was reported that the video generator board was found to be defective out of box.This is an out-of-box failure discovered by a getinge service engineer (fse).There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

The supplier returned the exchange video generator board to the getinge national repair center (nrc).The supplier reported that no trouble was found and the board passed testing.A technician of the nrc completed inspection of the board per procedure and no visual damage observed.The nrc installed the exchange video generator board into the cardiosave test fixture and tested the board to factory specifications per service bulletin and the cardiosave service manual.The board passed testing and will be returned to stock per procedure.

Event Description

It was reported that the video generator board was found to be defective out of box.This is an out-of-box failure discovered by a getinge service engineer (fse).There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

The suspected exchange video generator board was replaced at the time of the reported event.The suspected part was returned to the getinge national repair center (nrc) for further investigation.The technician of the nrc inspection the exchange video generator board per procedure and no visual damage was observed.The technician installed the exchange video generator board into the cardiosave test fixture and tested the board to factory specifications per service bulletin and cardiosave service manual.The technician observed an error code #6 on startup.This code relates to the touch screen configuration.Once the touchscreen was calibrated the code no longer appeared at startup.The board passed testing after the touchscreen was calibrated.The board was then sent to the supplier for failure analysis per procedure.

Event Description

It was reported that the video generator board was found to be defective out of box.This is an out-of-box failure discovered by a getinge service engineer (fse).There was no patient involvement 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: 8147826
• MDR Text Key: 129904342
• Report Number: 2249723-2018-02136
• 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: 05/21/2019

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 Model Number: N/A
• Device Catalogue Number: 0998-00-0800-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 07/01/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 03/19/2019; 05/01/2019
• Supplement Dates FDA Received: 04/12/2019; 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1