BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION MEDICAL FLOW METER

    MDR report key: 2026586 · Received March 17, 2011

    Report

    Report Number
    2523148-2011-00001
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 1, 2011
    Manufacturer
    PRECISION MEDICAL INC.
    Product Code
    CAX
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTIFIED BY HOSPITAL THAT THERE HAD BEEN A FIRE INCIDENT WITH A FLOW METER IN THE ICU WARD ON (B)(6) 2011. NOTIFIED BY HOSPITAL ON (B)(6) 2011. VISITED HOSPITAL ON (B)(6) 2011. FIRE OCCURRED IN THE ICU WARD, WITH A 2MFA FLOW METER. FLOW METER HAD BEEN OPERATING AT 10 LITERS PER MINUTE FOR SEVERAL DAYS. FIRE OCCURRED IN FLOW METER. CAUSE IS UNK, AT THIS TIME. FLOW METER WAS SENT TO AN OUTSIDE AGENCY (ECRI) FOR INVESTIGATION.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: NURSE NOTICED SOMETHING WAS NOT RIGHT WITH THE FLOW METER AND ASKED THE CHARGE NURSE TO CHECK THE FLOW METER. THE PT WAS ON AN OXYGEN FACE MASK CONNECTED TO THE FLOW METER INVOLVED IN THE INCIDENT. AS THE CHARGE NURSE ENTERED THE ROOM, SHE NOTICED THAT IT SMELLED LIKE SOMETHING WAS BURNING. SHE OBSERVED THAT THE FLOW TUBE WAS BLACK. SHE HAD RESPIRATORY THERAPY PAGED TO COME TO THE ROOM. SHE THEN BEGAN TO TURN DOWN THE FLOW METER, AS SHE WAS ADJUSTING THE FLOW METER, IT EXPLODED AND FLAMES BEGAN TO SHOOT OUT OF THE WALL. A CODE RED WAS INITIATED VIA THE PHONE. THE PT WAS IMMEDIATELY EVACUATED FROM THE ROOM AND THE DOOR TO THE ROOM WAS CLOSED. THE NURSING SUPERVISOR TURNED OFF THE OXYGEN TO HALF OF THE UNIT. SECURITY EXTINGUISHED THE BURNING PIECES. THERE WAS NO PT HARM, EMPLOYEE INJURY OR DAMAGE TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION MEDICAL FLOW METER OXYGEN FLOW METER CAX PRECISION MEDICAL INC. 2MFA1001 5/95

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR