BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAERIS 320

    MDR report key: 6459804 · Received April 3, 2017

    Report

    Report Number
    MW5068900
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    March 28, 2017
    Report Date
    April 3, 2017
    Manufacturer
    OXYHEALTH LLC
    Product Code
    CBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OVER THE PAST MONTH, THE INSIDE ZIPPER OF OUR OXYHEALTH VITAERIS 320 (SN (B)(4)) HAS COME APART UNDER THE NORMAL OPERATING PRESSURE OF 4LBS PRESSURE. BOTH THE TOP AND INSIDE (LOWER) ZIPPER WERE ENTIRELY ZIPPED TO THE END OF THE ZIPPERS. THE CHAMBER WAS INFLATED TO 4LBS (1.3ATA) PRESSURE FOR ABOUT TWO MINUTES AT FULL INFLATION BEFORE THERE WAS A LOUD NOISE AND THE INSIDE ZIPPER CAME APART, AND ALL AIR SUDDENLY EXHAUSTED FROM THE CHAMBER (RAPID DEFLATION). AFTER EXITING THE CHAMBER, I WAS ABLE TO SLIDE THE ZIPPER TO THE OTHER END OF THE TRACK, AND THEN IT ZIPPED UP FINE AGAIN TO THE HEAD-TOP END OF THE CHAMBER AND THE CHAMBER SEEMED TO WORK FINE. THE TOP ZIPPER WAS STILL TOTALLY ZIPPED AND NOT UNDONE AFTER THE INSIDE ZIPPER FELL APART. IT HAS DONE THIS THREE TIMES IN THE LAST MONTH. WE HAVE NOT USED THE CHAMBER SINCE THE LAST INCIDENT FOR FEAR OF INJURING PATIENTS. OXYHEALTH HAS SENT A ZIPPER REPAIR KIT AS A SOLUTION TO FIX THE ISSUE ON MY OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237697 VITAERIS 320 PORTABLE HYPERBARIC CHAMBER CBF OXYHEALTH LLC VITAERIS 320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention