BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC WITHOUT ALARMS

    MDR report key: 1459040 · Received May 23, 2009

    Report

    Report Number
    2182466-2009-00008
    Event Type
    Malfunction
    Date Received
    May 23, 2009
    Date of Event
    April 15, 2009
    Report Date
    April 27, 2009
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    BTL
    PMA / PMN Number
    K960515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL PM, INC. IMPORTS THE VENTILATOR FROM SMITHS MEDICAL (B)(4). SMITHS MEDICAL PM, INC. KITS A PATIENT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR, THEREFORE, SMITHS MEDICAL PM, INC. IS REPORTING AS THE MANUFACTURER. THE VENTILATOR WAS RETURNED TO SMITHS MEDICAL PM, INC. TECHNICAL SERVICE DEPT FOR EVALUATION. THE VENTILATOR CAME IN TURNED OFF WITH RELIEF PRESSURE SET AT 60, AIR MIX = 50%, FREQUENCY 12 BREATH/MIN TV = 50 ML. WHEN GAS WAS HOOKED TO THE VENT, IT DID NOT VENT OR LET O2 FLOW UNTIL THE UNIT WAS TURNED ON. DURING FUNCTIONAL TESTING, THE VALVE WAS NOISY DURING DEMAND TEST. THE TIDAL VOLUME ON AIR MIX WAS OUT OF TOLERANCE. THE NEEDLE BOUNCED AROUND DURING THE RELIEVE PRESSURE TEST. THE LOW FLOW WAS ADJUSTED AND RELIEF PRESSURE VALVE WAS LUBRICATED. THE EXPENDED SINTERED FILTER WAS REPLACED. DURING THE PERFORMANCE TESTING IN TECHNICAL SERVICE, THE VENTILATOR DID NOT STOP CYCLING. THE BIOMEDICAL ENGINEERING DEPARTMENT AT THE USER FACILITY DID NOT ATTACH A PATIENT CIRCUIT TO THE VENTILATOR DURING THEIR EVALUATION. IF THE DEMAND VALVE IS SENSITIVE AND NO CIRCUIT IS ATTACHED, THE BACK PRESSURE CAN BE LOW ENOUGH TO CAUSE FREE FLOW. THE VENTILATOR HAS BEEN IN THE FIELD SINCE (B)(4) 1999. THIS IS THE FIRST TIME THE VENTILATOR HAS BEEN RETURNED TO SMITHS MEDICAL PM, INC. FOR EVALUATION. THE USER FACILITY PERFORMS ACCURACY CHECKS EVERY 6 MONTHS. THE LAST TIME THE USER FACILITY PERFORMED AN ACCURACY CHECK WAS IN NOVEMBER 2008.

    Description of Event or Problem · 1

    PT WAS TRANSPORTED FROM (B)(6) A DISTANCE OF APPROXIMATELY 90 MILES. VENTILATOR FUNCTIONED NORMALLY DURING TRIP WITH SOURCE GAS FROM EMS VEHICLE. ON ARRIVAL, PATIENT WAS TRANSFERRED TO STRETCHER GAS SUPPLY AND VENTILATOR WOULD NOT CYCLE. NO PATIENT HARM WAS REPORTED. THE VENTILATOR WAS EVALUATED BY THE USER FACILITY BIOMEDICAL ENGINEERING DEPT. THE USER FACILITY ALLEGED THAT THE VENTILATOR FREE FLOWED O2 DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC PARAPAC WITHOUT ALARMS EMERGENCY VENTILATOR BTL SMITHS MEDICAL PM, INC. P20D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention