BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEALTHCARE M4735A

    MDR report key: 3143265 · Received March 11, 2013

    Report

    Report Number
    3143265
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS HEALTHCARE NORTH AMERICA
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN FULL ARREST. HAD "SHOCKABLE RHYTHM" FOR A VERY LIMITED TIME WHILE IN (B)(6) MEDICAL CENTER E.R. DEFIBRILLATOR FAILED TWICE DURING THIS TIME. SECOND DEFIBRILLATOR BROUGHT IN, HOWEVER, PATIENT NO LONGER HAD "SHOCKABLE RHYTHM" AND DEATH PRONOUNCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102891 PHILIPS HEALTHCARE M4735A HEARTSTART XL WITH AED AND PACING MKJ PHILIPS HEALTHCARE NORTH AMERICA M4735A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR