BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 14886581 · Received July 1, 2022

    Report

    Report Number
    2249723-2022-01560
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 9, 2022
    Report Date
    February 27, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, E1 (SITE COUNTRY), G3, G6, H2, H3, H4, H6 (MEDICAL DEVICE ¿ PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10. ADDITIONAL INFORMATION: EVENT SITE STATE: (B)(6). DURING PM A GETINGE FIELD SERVICE ENGINEER (FSE) FOUND MINOR DAMAGES AROUND THE CART, DISMANTLED THE SYSTEM AND RE-FITTED THE FOLLOWING PARTS, TOUCHSCREEN ASSEMBLY (0160-00-0123), PCBA ALARM DAUGHTERBOARD (0670-00-0860), TYPE I AC PWR CORD (012-00-1688-05), SAFETY DRIVE DISK (0202-00-0140) AND TIDAL VOLUME DISK (0202-00-0142). TESTED THE SYSTEM TO AS/NZS3551 MANUFACTURE SPECIFICATIONS, PERFORMED ALL SAFETY CHECKS AS PER GETINGE RECOMMENDATION THE UNIT WAS RETURNED BACK TO SERVICE FULLY FUNCTIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A FAULTY TOUCHSCREEN AND IS IN NEED OF A POWER CABLE. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCES THE EVENT OCCURRED OR IF THERE WAS ANY PATIENT INVOLVEMENT. SJOGBH RP CARDIOSAVE TOUCHSCREEN FAULTY. ON (B)(6) 2022- TOUCHSCREEN FAULTY AND NEEDS A POWER CABLE. CARDIOSAVE HYBRID TYPE I.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A FAULTY TOUCHSCREEN AND IS IN NEED OF A POWER CABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231838 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown