BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED10

    MDR report key: 2503272 · Received March 19, 2012

    Report

    Report Number
    3023750-2012-01014
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 28, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT (AGE & GENDER UNK) THE DEVICE WOULD NOT POWER UP. COMPLAINT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED10 AUTOMATED EXTERNAL DEFIB MKJ WELCH ALLYN PROTOCOL, INC AED10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK