BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC40, SPO2 & CHARGER

    MDR report key: 1920661 · Received December 6, 2010

    Report

    Report Number
    3023750-2010-01229
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Report Date
    November 16, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC40, SPO2 & CHARGER AUTOMATED EXTERNAL DEFIB MKJ WELCH ALLYN PROTOCOL, INC. PIC40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA