BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2009483 · Received February 17, 2011

    Report

    Report Number
    2009483
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED THAT THE TELEMETRY BOX (B) (6) FELT HOT, A SITTER IN THE ROOM CHECKED THE BOX AND BOX WAS INDEED HOT, WHEN SHE OPENED THE TELEMETRY BOX (B) (6), THE BATTERIES LOOKED AS IF THEY WERE MELTING. THE BOX WAS TAKEN OFF THE PATIENT. THE PATIENT WAS NEVER HARMED, THE OUTSIDE OF TELEMETRY BOX LOOKED NORMAL, SENT TO BIO MED.

    Description of Event or Problem · 1

    PATIENT COMPLAINED THAT THE TELEMETRY BOX NUMBER 58 FELT HOT, A SITTER IN THE ROOM CHECKED THE BOX AND BOX WAS INDEED HOT, WHEN SHE OPENED THE TELEMETRY BOX NUMBER 58, THE BATTERIES LOOKED AS IF THEY WERE MELTING. THE BOX WAS TAKEN OFF THE PATIENT. THE PATIENT WAS NEVER HARMED, THE OUTSIDE OF TELEMETRY BOX LOOKED NORMAL, SENT TO BIO MED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TELEMETRY TRANSMITTER, PHYSIOLOGICAL DRG NIHON KOHDEN AMERICA, INC. ZM541PA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *