BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17442416 · Received August 2, 2023

    Report

    Report Number
    2249723-2023-03469
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 24, 2023
    Report Date
    February 20, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SAFETY ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. CARDIOSAVE REPAIR - DAMAGED POWER CORD. FST - CONFIRMED THAT THE POWER CORD WAS CRACKING AROUND THE PLUG END. REPLACED THE POWER CORD REEL. NOTED THAT THE BATTERY PACKS WERE EXPIRING THIS MONTH. NEXT PM IS IN DECEMBER - SO REPLACED BOTH OF THE BATTERY PACKS. AFTER REPAIR FST PERFORMED A FULL PM AND CALIBRATION AND TESTED THE UNIT. THE PRODUCT PASSED ALL FUNCTIONAL/SAFETY TESTING. RETURNED THE UNIT TO THE CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED PART NUMBER 0012-00-1688-01 K AC POWER CORD REEL SERIAL NUMBER: (B)(6) AMETEK WITH A REPORTED UNIT FAILURE OF CRACKING ON AC POWER CORD INSULATION. THE FAT DEPARTMENT PERFORMED A VISUAL INSPECTION OF THE PART RECEIVED AND FOUND THAT THE AC POWER CORD INSULATION IS CRACKED. DUE TO THE CRACKED INSULATION OF THE AC POWER CORD, IT CANNOT BE INSTALLED AND INVESTIGATED ANY FURTHER. RETAINING THE AC POWER CORD REEL IN THE FAT DEPT. PER PROCEDURE (B)(4) REV.AS. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A NORMAL CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S POWER CORD RIP IN THE INSULATION. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466536 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown