BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 12204439 · Received July 21, 2021

    Report

    Report Number
    2249723-2021-01582
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 29, 2021
    Report Date
    February 28, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: E1 (EVENT SITE TELEPHONE: (B)(6).

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    DEVICE NOT ACCESSIBLE FOR TESTING: (4117/213) DEVICE IS NOT ACCESSIBLE FOR TESTING DUE TO THE CUSTOMER NOT REQUESTING REPAIR SERVICE. COMMUNICATION/INTERVIEWS: (4111/213) A GETINGE STM HAS CONVERSED WITH THE CUSTOMER AND WAS ADVISED THAT THE CUSTOMER HAS FIXED THE REPORTED ISSUE AND THE UNIT IS WORKING AS IT SHOULD. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS HAVING PRESSURE ISSUE. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100021 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 NA Prefer Not To Disclose