BEUDAMED
    FDA Adverse Event Other Summary report: N

    PNEUPAC PARAPAC WITHOUT ALARMS

    MDR report key: 850284 · Received May 15, 2007

    Report

    Report Number
    2182466-2007-00005
    Event Type
    Other
    Date Received
    May 15, 2007
    Report Date
    May 11, 2007
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    CBK
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING RETURNED TO SMITHS MEDICAL INT'L TO BE EVALUATED. THE RESULTS OF THE EVALUATION WILL BE SUBMITTED AFTER THE EVALUATION IS COMPLETED. SMITHS MEDICAL PM, INC. IMPORTS THE PNEUPAC PARAPAC WITHOUT ALARMS VENTILATOR FROM SMITHS MEDTICAL INTERNATIONAL, LTD. SMITHS MEDICAL PM, INC. KITS A DISPOSABLE PATIENT CIRCUIT (CAT. NO. 122002) AND PACKAGES THE DISPOSABLE PATIENT CIRCUIT ALONG WITH THE VENTILATOR FOR DISTRIBUTION IN THE UNITED STATES. THE USER FACILITY HAD INDICATED THAT AFTER THEY SWITCHED THE PT TO MANUAL VENTILATION, THEY INSPECTED THE REGULATOR, O2 HOSE, AND FILTER. THEY ALSO ATTACHED A NEW O2 TANK AND TRIED TO REPRODUCE THE FAULT BUT WERE UNABLE TO REPRODUCE IT. THE USER FACILITY ALSO INDICATED THAT THEY WERE NOT USING THE PATIENT CIRCUIT SUPPLIED FOR USE WITH THE VENTILATOR. THE PT CIRCUIT THEY WERE USING HAD AN IN-LINE HUMIDIFIER AND A BUILT IN SUCTION CATHETER. THE OPERATION MANUAL FOR THE VENTILATOR SPECIFICALLY WARNS AGAINST THE USE OF ALTERNATIVE VENTILATOR PATIENT CIRCUITS. WE HAVE RECEIVED VERY LITTLE INFORMATION AS INDICATED IN THE REPORT FROM THE USER FACILITY. WE ARE CONTINUING TO FOLLOW UP WITH THE USER FACILITY TO GATHER MORE INFORMATION REGARDING THE INCIDENT.

    Description of Event or Problem · 1

    PT WAS BEING TRANSPORTED AND BEING VENTILATED USING A PNEUPAC PARAPAC VENTILATOR WITHOUT ALARMS. AFTER APPROXIMATELY 1/2 HOUR, THE VENTILATOR ALLEGEDLY STOPPED CYCLING. THE PT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED. THE PATIENT DID NOT SUFFER ANY NEGATIVE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC PARAPAC WITHOUT ALARMS EMERGENCY VENTILATOR CBK SMITHS MEDICAL PM, INC. PARAPAC 20D

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention