BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M4841A S01 ECG ONLY TELEMETRY TRANSMITTER (FINISHED)

    MDR report key: 12277483 · Received August 4, 2021

    Report

    Report Number
    3007409280-2021-00016
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 13, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    K041741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE STATES: DOESN'T POWER ON AND GETS WARM AFTER THE BATTERIES ARE INSTALLED FOR A LITTLE WHILE. IT RETURNED FROM REPAIR 5/18/2021 AND WAS PUT BACK INTO SERVICE (B)(6) 2021 (AS FOUND THE BATTERIES WERE INSTALLED CORRECTLY AND WARM TO THE TOUCH). IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. TECHNICAL EVALUATION IDENTIFIED EXTENSIVE FLUID INTRUSION AND DAMAGE TO ALL INTERNAL COMPONENTS. ADDITIONALLY, ALL PCB'S HAD SLIGHT CORROSION FROM FLUID INTRUSION. THERE WAS NO POWER RUNNING THROUGH THE ECG PCB NOR THE POWER PCB. THE DEVICE WILL NEED TO BE EXCHANGED IN ORDER TO REPAIR. THE CUSTOMER COMPLAINT WAS CONFIRMED; HOWEVER, THE DAMAGES FOUND WERE NOT RELATED TO A PREVIOUS SERVICE OR REPAIR. THE ROOT CAUSE WAS DETERMINED TO BE FLUID INTRUSION DAMAGES RESULTING IN THE FAILURE OF INTERNAL PARTS AND COMPONENTS. THE DEVICE WILL BE EXCHANGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE REPORTED ISSUE STATES: DOESN'T POWER ON AND GETS WARM AFTER THE BATTERIES ARE INSTALLED FOR A LITTLE WHILE. IT RETURNED FROM REPAIR 5/18/2021 AND WAS PUT BACK INTO SERVICE (B)(6) 2021 (AS FOUND THE BATTERIES WERE INSTALLED CORRECTLY AND WARM TO THE TOUCH). IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175817 PHILIPS M4841A S01 ECG ONLY TELEMETRY TRANSMITTER (FINISHED) M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TEL MHX PHILIPS MEDICAL SYSTEMS, INC. FTPH3100

    Patients

    Seq Age Sex Outcome Treatment
    1