BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1032386 · Received April 16, 2008

    Report

    Report Number
    3023750-2008-00104
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 8, 2008
    Report Date
    March 19, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT ADD'L TIME IS REQUIRED TO COMPLETE THE INVESTIGATION. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ECG LEADS WOULD NOT READ. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC 50

    Patients

    Seq Age Sex Outcome Treatment
    1