BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MEDICAL

    MDR report key: 481379 · Received August 22, 2003

    Report

    Report Number
    MW1029401
    Event Type
    Injury
    Date Received
    August 22, 2003
    Date of Event
    August 20, 2003
    Report Date
    August 22, 2003
    Manufacturer
    PRECISION MEDICAL
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 2/17/04: UNIT WAS INSTALLED ON A OXYGEN E TANK. THE DEVICE WAS NOT IN SERVICE WHEN THE INCIDENT OCCURRED. THE OUTSIDE HOUSING OF THE FLOWMETER BLEW OFF, HITTING THE CEILING ABOVE THE TANK. ASSUMPTION IS THAT THE POST VALVE ON THE E TANK WAS LEFT OPEN, AND THE AJUSTMENT KNOB ON THE FLOWMETER WAS IN THE OFF POSITION, SEE ATTACHED PHOTOGRAPH FOR CLARIFICATION OF THE SET UP AND THE DEVICE. THE RESULTS OF THE FAILURE ANALYSIS: THE DEVICE WAS RETURNED TO PRECISION MEDICAL INC IN PIECES, THE THREADS ON THE FLOW TUBE HOUSING WERE DAMAGED, AND THE FLOAT BALL WAS MISSING. THE REGULATOR AND THE BASE OF THE FLOWMETER WERE INTACT, AND FUNCTIONED WITHIN LIMITS. THE DEVICE WAS REASSEMBLED WITH A NEW HOUSING, FLOAT BALL, AND TUBE. THE DEVICE WAS THEN TESTED TO RELEASE SPECIFICATION. ALL FLOW TESTING OF THE DEVICE WAS SUCCESSFUL. CONCLUSION WAS THAT THE OUTER HOUSING WAS EITHER NOT TIGHTENED DOWN COMPLETELY, OR THE HOUSING THREADS WERE DAMAGED IN A WAY TO WEAKEN THEM, ALLOWING THE HOUSING TO COME OFF. THE DEVICE WAS RETURNED TO PRECISION MEDICAL, INC ON 09/15/2003. THE DEVICE WAS TESTED AND HELD FOR SEVERAL MONTHS, NO RESPONSE WAS HEARD FROM THE HOSPITAL, THE DEVICE HAS BEEN DISCARDED. NO DESIGN CHANGES HAD BEEN MADE SINCE IT WAS FIRST RELEASED. THE LAST MODEL 1600M FLOW METER WAS INVOLVED IN OCTOBER 2003. PRECISION MEDICAL, INC STOPPED MANUFACTURING THE DEVICE IN OCTOBER OF 2003. THE DEVICE WAS DISCONTINUED DO TO LOW SALES.

    Description of Event or Problem · 1

    PRECISION MEDICAL OXYGEN REGULATOR FOR E-TANK SPONTANEOUSLY BLEW OFF E-TANK UPWARD. ACTION RESULTED IN THE REGULATOR PENETRATED ACCOUSTIC CEILING TILE ABOVE TANK WHILE TANK WAS SITTING UNIMPEDED IN ITS CYLINDER HOLDER. NO DAMAGE TO TANK AND PERIPHERAL EQUIPMENT IS NOTED. NO PTS WERE PRESENT AT TIME OF INCIDENT. STAFF RESPONDED IMMEDIATELY AND REPORTED INCIDENT TO SAFETY OFFICER. MODEL AND LOT NUMBERS WERE RECORDED. ALL ITEMS OF THAT TYPE AND BRAND WERE REMOVED FROM SERVICE AND REPLACED WITH ANOTHER MANUFACTURER'S REGULATORS PENDING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION MEDICAL OXYGEN E-TANK REGULATOR CAN PRECISION MEDICAL 1600M 080701

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention