BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9500 RESPIRATION/HEART RATE MONITOR

    MDR report key: 41137 · Received September 9, 1996

    Report

    Report Number
    2183157-1996-00018
    Event Type
    Malfunction
    Date Received
    September 9, 1996
    Date of Event
    August 4, 1996
    Report Date
    August 9, 1996
    Manufacturer
    AEQUITRON MEDICAL, INC.
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT OF ALLEGED "NO AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9500 RESPIRATION/HEART RATE MONITOR BREATHING FREQUENCY MONITOR FLS AEQUITRON MEDICAL, INC. 9500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other