BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATORY VENTILATOR

    MDR report key: 51941 · Received November 21, 1996

    Report

    Report Number
    2050001-1996-00023
    Event Type
    Malfunction
    Date Received
    November 21, 1996
    Date of Event
    October 25, 1996
    Report Date
    November 20, 1996
    Manufacturer
    SENSORMEDICS, SUBSIDIARY OF THERMO ELECTRON
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 3100A DID NOT OPERATE PROPERLY. THE LED INDICATOR ON THE PWM APLIFIER SHOULD BE RED BUT WAS ACTUALLY GREEN WHEN THE POWER WAS TURNED ON. THERE WAS NOT PT INVOLVEMENT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY OSCILLATORY VENTILATOR NEONATAL VENTILATOR LSZ SENSORMEDICS, SUBSIDIARY OF THERMO ELECTRON 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA