BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS

    MDR report key: 91962 · Received May 16, 1997

    Report

    Report Number
    91962
    Event Type
    Injury
    Date Received
    May 16, 1997
    Date of Event
    February 27, 1997
    Report Date
    March 6, 1997
    Manufacturer
    SIEMENS
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    2/27/97- NURSE REPORTED PEEP (MANOMETER) READ 8- DIAL SET AT 4. RESPIRATORY THERAPIST MADE AN ADJUSTMENT. PEEP APPEARED TO BE AT THE ORDERED LEVEL OF 4 BUT THE PT'S RESPIRATORY STATUS BEGAN TO DETERIORATE. 6 HOURS AFTER THIS EVENT, PT DIAGNOSED WITH A PNEUMOTHORAX. MANOMETER OBSERVED HOURLY 2/26/97-2300-SET AT 4 2/26/97-2400-SET AT 4-READ 8

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS VENTILATOR CBK SIEMENS 900C *

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5 YR Hospitalization| L| R