BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 500E INFANT MONITOR

    MDR report key: 131147 · Received November 4, 1997

    Report

    Report Number
    1216774-1997-00009
    Event Type
    Malfunction
    Date Received
    November 4, 1997
    Date of Event
    September 1, 1997
    Report Date
    November 4, 1997
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS DROPPED AT THE PTS HOME. THE CAREGIVER TESTED THE MONITOR AND NOTED THAT THE AUDIO INDICATOR DID NOT FUNCTION. THE ACCOUNT RETRIEVED THE MONITOR AND SENT IT IN FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 500E INFANT MONITOR ECG/RESPIRATION MONITOR FLS COROMETRICS MEDICAL SYSTEMS, INC. 500E *

    Patients

    Seq Age Sex Outcome Treatment
    1 *