BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 1338207 · Received March 6, 2009

    Report

    Report Number
    MW5010223
    Event Type
    Injury
    Date Received
    March 6, 2009
    Date of Event
    February 6, 2009
    Report Date
    March 4, 2009
    Product Code
    DRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PHILIPS TELEMETRY TRANSMITTER BECAME VERY HOT WHILE IN USE ON A PATIENT. THE NURSING STAFF NOTICED THE SMELL OF THE OVERHEATED TRANSMITTER. NURSING STAFF REPLACED THE TRANSMITTER AND THE BIOMED WAS ABLE TO EXAMINE IT ON THE NEXT BUSINESS DAY. SOME SMALL PLASTIC FEATURES INSIDE THE BATTERY COMPARTMENT WERE FOUND TO BE BROKEN OFF AND THIS ALLOWED THE SPRING BATTERY CONTACTS TO BE DISLOCATED IN A WAY THAT ALLOWED THE NEGATIVE CONTACT TO TOUCH THE POSITIVE CONTACT. THIS SHORT CIRCUITED THE BATTERY, OVERHEATING THE BATTERY AND THE TRANSMITTER. THE DESIGN OF THE BATTERY ENCLOSURE AND SPRING CONTACTS MAKES THESE DEVICES EASILY SUSCEPTIBLE TO THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS TELEMETRY TRANSMITTER DRG M2601B

    Patients

    Seq Age Sex Outcome Treatment
    1