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

Model Number 0998-00-0800-53

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/213): during a preventative maintenance (pm) service, the getinge field service engineer (fse) found that the unit would not charge the batteries while in the cart, he verified the issue was related to the power management board.To fix the issue, the fse replaced the power management board and performed a full pm with calibration, functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), he found that the cardiosave intra-aortic balloon pump (iabp) was not charging.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The suspected faulty power management board was returned to getinge's national repair center (nrc) for failure investigation.The nrc inspected the board per procedure and damage was observed to component q27 which was shorted.Due to the shorting of q27, the nrc was not able to test the power management board in the cardiosave test fixture.The power management board has been sent to the supplier for failure analysis per procedure.A supplemental report will be submitted when additional information is provided.

Manufacturer Narrative

*the aware date reported in the initial report was submitted incorrectly.The aware date should read: 11aug2021 the power management board was returned back to the nrc from the supplier.The supplier verified the failure of the unit not charging batteries, and replaced q27.The board passed testing.The nrc installed the board into the cardiosave test fixture and tested the board to factory specifications per procedure and the cardiosave service manual.The board passed testing.The board will be retained in the nrc per procedure.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Event Description

N/a.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12417919
• MDR Text Key: 271945121
• Report Number: 2249723-2021-02002
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.