BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 13668110 · Received March 4, 2022

    Report

    Report Number
    2249723-2022-00454
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 6, 2022
    Report Date
    January 29, 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
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF ACTUAL/SUSPECTED DEVICE/10: A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE EVALUATED THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT AND FOUND A BURNT CART BULK POWER SUPPLY BOARD. THERE WAS ALSO A MELTED AC POWER CORD CONNECTOR ON THE BOARD AND THE UNIT WAS STUCK IN THE CART AND UNABLE TO LOCK. TO FIX THE ISSUE, THE FSE REALIGNED THE PIN OF THE LOCKING MECHANISM, ALONG WITH REPLACING THE REEL, AC POWER CORD, DOMESTIC, TDK LAMBD, PAPER RECORDER, BOX 10 ROLLS, PCB,POWER SUPPLY MONITOR,ROHS, SCREW KIT, CARDIOSAVE CART PSU/HE REG. AND THE CART BULK POWER SUPPLY SPEC.THE FSE PERFORMED 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.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE EVALUATED THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT AND FOUND A BURNT CART BULK POWER SUPPLY BOARD. THERE WAS ALSO A MELTED AC POWER CORD CONNECTOR ON THE BOARD AND THE UNIT WAS STUCK IN THE CART AND UNABLE TO LOCK. TO FIX THE ISSUE, THE FSE REALIGNED THE PIN OF THE LOCKING MECHANISM, ALONG WITH REPLACING THE REEL, AC POWER CORD, DOMESTIC, TDK LAMBD (0012-00-1688-21), PAPER RECORDER, BOX 10 ROLLS (0683-00-0422-02), PCB,POWER SUPPLY MONITOR,ROHS (0670-00-1166), SCREW KIT, CARDIOSAVE CART PSU/HE REG. (0040-00-0458-11) AND THE CART BULK POWER SUPPLY SPEC (0014-00-0258).THE FSE PERFORMED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT UNEXPECTEDLY SHUTDOWN AFTER THE CUSTOMER SMELLED SOMETHING BURNING. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598115 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown