BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL COMPRESSOR

    MDR report key: 2093532 · Received April 5, 2011

    Report

    Report Number
    3005245901-2011-00001
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    December 24, 2010
    Report Date
    February 21, 2011
    Manufacturer
    EKOM SPOL. S.R.O.
    Product Code
    BTI
    PMA / PMN Number
    K060781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL C230 IS "SIMILAR DEVICE" TO THE MODELS DK50 D/DM CLEARED 510(K) K060781. C230 DOES NOT HAVE USED ACOUSTIC HIGH TEMPERATURE ALARM BUT THIS ALARM IS INCORPORATED TO THE MODEL DK50 D/DM.

    Description of Event or Problem · 1

    SPEAKS CLINICAL ENGINEER: I HAVE ONE E100M THAT'S IN THE WORKSHOP FOR INSPECTION. APPARENTLY THIS VENTILATOR IS USED WITH THE COMPRESSOR AT (B)(6) HOSPITAL (B)(6), WHEN I WENT TO FETCH THE VENTILATOR AT HTS-CE, I SAW THAT THE COMPRESSOR WAS BADLY BURNT (FIRE). THEY SAID THEY WILL CONDEMN THE COMPRESSOR AND THEY WANT ME TO INSPECT THE VENTILATOR, ON INSPECTION I HAVEN'T FOUND ANY FAULT THUS FAR EXCEPT THAT ITS SMELLING SMOKE ON THE INSIDE SINCE THERE WAS FIRE COMING FROM THE COMPRESSOR. I SPOKE TO THE DOCTOR AT THE HOSPITAL, HE SAID THE VENTILATOR WAS IN USE AT THE TIME OF INCIDENT AND FORTUNATELY THE CHILD WAS NOT INJURED. THE COMPRESSOR IS A NEWPORT C230 BUT THE SERIAL NUMBER CANNOT BE SEEN (IT WAS BURNT). ALL I GATHERED FROM THE NURSING STAFF IS THAT THERE WAS AN ALARM, THEY DID NOT KNOW WHETHER IT WAS A VENTILATOR OR COMPRESSOR AND THEY TRIED TO SILENCE THE VENTILATOR, IT COULDN'T SILENCE AND THEY CONTINUED USING THE VENTILATOR UP UNTIL THE INCIDENT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL COMPRESSOR 73 BTI BTI EKOM SPOL. S.R.O. C230

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO VENTILATOR E100M: SN (B)(4)