BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAHI HBO CHAMBER

    MDR report key: 2075477 · Received April 18, 2011

    Report

    Report Number
    2075477
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    December 1, 2010
    Report Date
    April 18, 2011
    Manufacturer
    PAN-AMERICA HYPERBARICS INC
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS TREATED FOR DIABETIC FOOT ULCER. PT'S 25TH TREATMENT WITH HISTORY OF SINUS CONGESTION. THE DOOR LATCH DISLODGED, RESULTING IN SUDDEN DECOMPRESSION OF THE CHAMBER. PT C/O COMPLAINED OF LIGHT HEADEDNESS AND EAR TENDERNESS. STAFF NOTIFIED VENDOR ABOUT THE INCIDENT AND PAN-AMERICA HYPERBARICS INC RESPONDED WITH A SITE VISIT WITHIN 24 HOURS. PAHI REPLACED THE OUTER STEEL LATCH HANDLE AND ULTIMATELY REPLACED THE ENTIRE DOOR LATCH OF THIS CHAMBER AND THE OTHER HYPERBARIC OXYGEN CHAMBER.======================MANUFACTURER RESPONSE FOR HYPERBARIC OXYGEN CHAMBER, PAHI HBO CHAMBER======================MANUFACTURER FIXED THE DOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAHI HBO CHAMBER HYPERBARIC OXYGEN CHAMBER CBF PAN-AMERICA HYPERBARICS INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR