BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED10

    MDR report key: 2512871 · Received March 27, 2012

    Report

    Report Number
    3023750-2012-01010
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Report Date
    March 9, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN 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 NA