BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-TWO ADULT VENTILATION TIMER

    MDR report key: 4852956 · Received June 16, 2015

    Report

    Report Number
    9610861-2015-00001
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 8, 2015
    Report Date
    June 11, 2015
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Product Code
    BTM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) EMS REPORTED THE FOLLOWING DEVICE MALFUNCTION OF O-TWO ADULT VENTILATION TIMER (P/N # 01BM1000): WHILE TREATING A PATIENT OF A SUSPECTED OPIOID OVERDOSE WITH RESPIRATORY DEPRESSION, THE O-TWO SMART BAG WITH AN ADULT VENTILATION TIMER LIGHT WAS USED TO BREATHE FOR THE PATIENT. DURING THE COURSE OF CARE THE PARAMEDIC PROVIDING VENTILATIONS NOTICED THE ADULT VENTILATION TIMING LIGHT WAS BLINKING AT A HIGHER RATE THAN THAT STATED ON THE DEVICE. THEY DESCRIBED IT AS ABOUT 20-24 BLINKS/MINUTE. THE DEVICE IS LABELED F = 10/MIN. THIS TIMING LIGHT IS ACTIVATED TO GUIDE THE PERSON PROVIDING THE PATIENT VENTILATIONS TO BREATHE AT A RATE APPROPRIATE FOR ADULTS. IN THIS CASE THE LIGHT WAS FLASHING AT A RATE CONSISTENT WITH A PEDIATRIC PATIENT. THERE IS THE POTENTIAL THAT AN ADULT PATIENT IN CARDIAC ARREST IS VENTILATED AT A FASTER RATE THAN RECOMMENDED, HYPERVENTILATING PATIENTS DURING ARREST REDUCES THE EFFICACY OF COMPRESSIONS DURING CPR. THE SUSPECT SAMPLE WAS RETURNED ON 05/22/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392616 O-TWO ADULT VENTILATION TIMER TIMER, GENERAL LABORATORY BTM O-TWO MEDICAL TECHNOLOGIES, INC. 01BM1000 079810

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other SMART BAG MO