BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIK-COMBO RTS DEFIBRILLATION/ECG ELECTRODES

    MDR report key: 1346469 · Received March 17, 2009

    Report

    Report Number
    3015876-2009-00317
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    December 23, 2008
    Report Date
    February 16, 2009
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MLN
    PMA / PMN Number
    K960329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE HOSPITAL AND IS NOT AVAILABLE FOR EVALUATION. PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE REPORTED EVENT. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN EMERGENCY RESUSCITATION, A HOSPITAL NURSE EXPERIENCED A SERIOUS INJURY AFTER SLIPPING AND FALLING WHEN SHE STEPPED ON THE ELECTRODE RELEASE LINER THAT WAS ON THE FLOOR. IT WAS REPORTED THAT THE NURSE SUSTAINED MULTIPLE FRACTURES AND DISLOCATIONS OF THE ANKLE REQUIRING SURGERY AFTER SHE SLIPPED ON THE CLEAR PLASTIC BACKING OF A DEFIB PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIK-COMBO RTS DEFIBRILLATION/ECG ELECTRODES MLN PHYSIO-CONTROL, INC. NA 603430

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R