BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17551975 · Received August 15, 2023

    Report

    Report Number
    2249723-2023-03709
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    August 8, 2023
    Report Date
    June 26, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS, COMPONENT CODES & INVESTIGATION CONCLUSIONS), H10. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND BATTERY PACKS HAVE CHARGE BUT ARE NOT CHARGING IN THE CART. IT WAS DISCOVERED THE FIBER OPTIC COVER ON THE UPPER PANEL WAS BROKEN. THE SCREW, WASHER & SPRING HOLDING THE COVER FELL ONTO THE POWER MANAGEMENT PCB CAUSING AN ELECTRICAL SHORT. IABP POWERED ON ONCE POWER MANAGEMENT PCB WAS REPLACED. IT WAS THEN DISCOVERED THAT THE THERMAL PRINTER AND PRINTER INTERFACE PCBA WERE ALSO DAMAGED. BOTH WERE REPLACED. NEW UPPER PANEL WAS ALSO INSTALLED. COMPLETE PM PERFORMED WITH FULL CALIBRATION, FUNCTIONAL TESTING AND ELECTRICAL SAFETY CHECKS TO FACTORY SPECIFICATIONS. UNIT RETURNED TO CUSTOMER AND CLEARED FOR CUSTOMER USE. THE FAILURE ANALYSIS AND TESTING DEPT. (FAT) RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0670-00-1162 REV. E, SERIAL NUMBER (B)(6) . PART NUMBER 0997-00-0644. PART NUMBER 0161-00-0024-04 REV. C, SERIAL NUMBER (B)(6). PART NUMBER 0670-00-1168 REV. A, SERIAL NUMBER (B)(6) . THE FAT PERFORMED A VISUAL INSPECTION AND FOUND: PN 0670-00-1162 HAD DAMAGE TO THE BOARD. WHITE RESIDUE OBSERVED. PN 0997-00-0644 HAS A MISSING FIBER OPTIC DOOR. PN 0161-00-0024-04 HAS DAMAGE TO THE BOARD. WHITE RESIDUE OBSERVED. PN 0670-00-1168 HAS SOME SLIGHT DAMAGE NEAR THE CONNECTOR. WHITE RESIDUE OBSERVED. THESE PARTS WERE RECEIVED WITH A REPORTED FAILURE OF ELECTRICAL SHORTS ON THE BOARDS. THE PARTS OBSERVED HAVE WHITE RESIDUE WHICH IS CONSISTENT WITH SALINE. DUE TO THE RISK ASSOCIATED TO THE CARDIOSAVE TEST FIXTURE, FAT CANNOT INSTALL AND TEST THESE PARTS. FAT WAS ABLE TO VERIFY THE ISSUE REPORTED. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROUTINE CHECK PERFORMED BY CUSTOMER THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) NOT POWERING ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792665 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown