BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIATELE TELEMETRY TRANSMITTER

    MDR report key: 8113497 · Received November 28, 2018

    Report

    Report Number
    3010157426-2018-00086
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    July 5, 2018
    Report Date
    December 11, 2018
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K121480
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TELEMETRY TRANSMITTER IN QUESTION HAS BEEN INSPECTED BY SPACELABS. RESIDUE WAS FOUND IN THE BATTERY COMPARTMENT THAT SUGGESTS THAT THERE HAD BEEN LIQUID INSIDE OF THE COMPARTMENT. ALSO, THE BATTERY SPRINGS WERE FOUND TO BE SLIGHTLY BENT UPWARD. THIS PARTICULAR TRANSMITTER IS NO LONGER IN SERVICE. THIS REPORT IS COMPLETE AND THIS ISSUE IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON (B)(6) 2015 THAT A PATIENT SUFFERED BURNS TO HIS CHEST (RED MARKS) FROM A TELEMETRY TRANSMITTER. THE NURSE BURNT HER FINGERS WHEN REMOVING THE AA BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948972 ARIATELE TELEMETRY TRANSMITTER ARIATELE MHX SPACELABS HEALTHCARE INC. 96281

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other