BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATORY VENTILATOR

    MDR report key: 255699 · Received December 17, 1999

    Report

    Report Number
    2050001-1999-00119
    Event Type
    Malfunction
    Date Received
    December 17, 1999
    Date of Event
    December 1, 1999
    Report Date
    December 16, 1999
    Manufacturer
    SENSORMEDICS CORP.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE TREATING A PT, THE OSCILLATORY PRESSURE (DELTA-P) ON THE MODEL 3100A DROPPED FROM 18 TO 2 CMH2O CAUSING THE 3100A TO ALARM. THE PT WAS PLACED ON ANOTHER 3100A WITHOUT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY OSCILLATORY VENTILATOR NEONATAL/PEDIATRIC VENTILATOR LSZ SENSORMEDICS CORP. 3100A -

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN