BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 511 MONITOR

    MDR report key: 86102 · Received April 16, 1997

    Report

    Report Number
    1216774-1997-00003
    Event Type
    Malfunction
    Date Received
    April 16, 1997
    Date of Event
    March 24, 1997
    Report Date
    April 15, 1997
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MONITOR WAS RETURNED FOR SERVICE ON 3/12/97 TO REPLACE A DEAD BATTERY. DURING EVAL OF THE MONITOR'S BATTERY PERFORMANCE ON 3/24/97, SVC REP NOTED THAT THE MONITOR TURNED OFF WITHOUT GIVING AN AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 511 MONITOR CARDIO-RESPIRATORY MONITOR FLS COROMETRICS MEDICAL SYSTEMS, INC. 511 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *