BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 18868800 · Received March 8, 2024

    Report

    Report Number
    2249723-2024-00979
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 27, 2024
    Report Date
    December 9, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D9,G3,G6,H2,H3,H4,H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS,COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10. ADDITIONAL FIELDS: E1(EVENT SITE STATE: 16, EVENT SITE POSTAL CODE: 16000). IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DEVICE "POWER CABLE DAMAGED". A GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THAT AC LINE CORD OF THE DEVICE WAS DEFORMED AND ITS OUTER PLASTIC COATING WAS TORN. AC LINE CORD NEEDS TO BE REPLACED WITH A NEW ONE. PARTS HAVE BEEN ORDERED. REPLACED AC POWER CORD (D012-00-1823-02), DEVICE WAS TESTED WITH A TEST TRAINER AND CATHETER THE DEVICE WAS DELIVERED IN WORKING CONDITION. THE DEVICE IS SUITABLE FOR CLINICAL USE. PATIENT INVOLVEMENT WAS NOT THERE, NO HARM REPORTED.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.E1 EVENT SITE NAME WAS SHORTENED DUE TO CHARACTER LIMITATIONS. THE COMPLETE NAME IS (B)(6).

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) POWER CORD WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700447 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown