BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINAIR

    MDR report key: 1202099 · Received October 16, 2008

    Report

    Report Number
    1625774-2008-00047
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Report Date
    September 17, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FOLLOW-UP WITH THE MEDICAL CENTER BY KCI MEDICAL STAFF, IT WAS DETERMINED THAT THE PLUG INADVERTENTLY DISCONNECTED FROM THE UNDER-BED INVERTER. THE NURSING STAFF WAS ALERTED TO THE DEFLATION WHEN THE PATIENT BECAME AROUSED AND AGITATED, CAUSING THE VENTILATOR TO ALARM. THE CAREGIVER STATED THAT HE DID NOT HEAR THE BED'S DEFLATION ALARM. QC CHECK OF THE BED FOLLOWING THIS EVENT IN 2008 INDICATED THAT THE BED WAS FUNCTIONING PROPERLY, INCLUDING BED ALARMS AND BACK-UP BATTERY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO KCI IN 2008, THAT WHEN THE KINAIR MEDSURG BED POSITION WAS BEING CHANGED BY MEDICAL STAFF, THE ELECTRICAL PLUG DETACHED FROM UNDER THE BED. IT WAS REPORTED THAT SUBSEQUENTLY THE BED'S BACK-UP BATTERY DEPLETED, CAUSING THE BED TO DEFLATE. IT WAS ALLEGED THAT THIS CAUSED THE INTUBATED PATIENT TO MOMENTARILY CHOKE ON HER BREATHING TUBE. THERE WAS NO REPORTED INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR IOQ KCI USA, INC. MEDSURG

    Patients

    Seq Age Sex Outcome Treatment
    1