BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC VENTILATOR

    MDR report key: 8030884 · Received November 1, 2018

    Report

    Report Number
    3012307300-2018-08038
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 8, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: ONE PARAPAC PLUS (PERT NUMBER 530A1166NJP/ SERIAL NUMBER (B)(4)) WAS RECEIVED WITH A BATTERY AND PATIENT CIRCUIT (LOT 160718). NO DAMAGE WAS NOTED TO THE UNIT OR THE CIRCUIT DURING VISUAL INSPECTION. FUNCTIONAL TESTING FOUND NO FAULT WITH THE DEVICE OR PATIENT CIRCUIT. ALL FUNCTIONS WERE FOUND TO BE CORRECT AND WITHIN SPECIFICATIONS. THE INVESTIGATOR TRIED TO RECREATE THE FOLLOWING REPORTED PRODUCT PROBLEM: "DURING MAINTENANCE OF THE PRODUCT, THE CUSTOMER NOTICED THE AIR SUPPLY FOR INHALATION BREATH WOULD NOT STOP AND COULD NOT BE SWITCHED TO THAT FOR EXHALATION BREATH EVEN WHEN THE MODE WAS SWITCHED TO "AIR VENTILATION".' THE UNIT WAS REPEATEDLY TESTED AT VARIOUS INPUT PRESSURES RANGING FROM 41-90 PSI (INPUT GAS PRESSURE RANGE STATED ON THE UNIT). THE UNIT CONTINUED TO FUNCTION CORRECTLY AT ALL SETTINGS. THE REPORTED FAULT COULD NOT BE CONFIRMED; THE UNIT FUNCTIONED CORRECTLY AND WITHIN SPECIFICATIONS AT ALL SETTINGS.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC PARAPAC VENTILATOR FAILED TO STOP THE AIR INTAKE SUPPLY DURING MAINTENANCE TESTING. ADDITIONALLY, THE VENTILATOR WOULD NOT SWITCH TO "EXPIRATION," EVEN WHEN THE MODE WAS SWITCHED TO "AIR VENTILATION". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869579 PNEUPAC PARAPAC VENTILATOR VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1