BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNA

    MDR report key: 1921016 · Received December 7, 2010

    Report

    Report Number
    3015876-2010-01338
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 1, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K895379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL REP EVALUATED THE DEVICE AND VERIFIED THE REPORTED TEAR OF THE RUBBER COVER OVER THE SHOCK BUTTON. A REPLACEMENT INTERNAL PADDLE CABLE ASSEMBLY WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    AFTER STEAM STERILIZATION, IT WAS OBSERVED THAT THE RUBBER COVER OVER THE SHOCK BUTTON OF THE INTERNAL HANDLE WAS TORN. THE CUSTOMER HAD USED THE INTERNAL HANDLES 15 TIMES. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNA LDD PHYSIO-CONTROL, INC NA 0904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA