BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 2001832 · Received February 17, 2011

    Report

    Report Number
    2023050-2011-00004
    Event Type
    Other
    Date Received
    February 17, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 20, 2011
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IS BETWEEN (B)(6). EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. EVALUATION OF THE RETURNED VENTILATOR DUPLICATED THE MOTOR FAULT ERROR MESSAGE WHEN THE VENTILATOR WAS PRESSED ON/STANDBY BUTTON TO START VENTILATION. A VISUAL INSPECTION WAS PERFORMED. THE BATTERY PLATE WAS REMOVED TO CHECK THE MANIFOLD CONNECTION AND IT WAS FOUND THAT ONE PIN WAS DISLODGED FROM THE MANIFOLD CONNECTOR. IT WAS CONCLUDED THAT THE DISLODGED CONNECTOR PIN DIRECTLY CAUSED THE MOTOR FAULT ERROR. THIS TYPE TO MANIFOLD CONNECTOR IS A MOLEX 8 PIN CONNECTOR WHICH USES A MALE AND FEMALE PUSH PIN. THERE IS A PRONG THAT STICKS OUT OF EACH SIDE. WHEN THIS PIN IS PUSHED INTO THE CONNECTOR; THE PRONG LOCKS IN PLACE AND THE PIN CANNOT BE REMOVED AS IT IS SEATED INTO THE CONNECTOR; THE ONLY WAY TO REMOVE IT IS WITH A PIN PUSHER. FROM THE INVESTIGATION OF THE RETURNED UNIT, THIS PIN WAS HALF WAY OUT WHEN THE VENTILATOR WAS OPENED FOR VISUAL INSPECTION. IT IS MOST LIKELY THAT THIS PIN WAS NOT COMPLETELY PUSHED IN ORIGINALLY AND BECAME UNDONE DURING THE LAST SERVICE AND/OR DURING THE SHIPMENT TO THE CUSTOMER. IT WAS FOUND THAT THIS VENTILATOR WAS LAST SERVICED BY THE MFR, NEWPORT MEDICAL, IN (B)(6) 2010. AT THAT TIME AN OPERATION VERIFICATION PROCEDURE WAS PERFORMED AND ALL TESTS WERE SUCCESSFULLY PASSED PRIOR TO SHIPPING BACK TO THE CUSTOMER. IT WAS ALSO NOTICED FROM THE SERVICE HISTORY THAT THE WORKING HOURS RECORDED ARE THE SAME AS THE HOURS RECORDED WHEN THE VENTILATOR WAS RECEIVED FOR THIS ISSUE. AS A PREVENTIVE MEASURE, ALL THE NEWPORT SERVICE TECHNICIANS WERE NOTIFIED OF THIS TISSUE AND RETAINED TO VERIFY THAT ALL PINS ARE FIRMLY CONNECTED TO BOARDS BEFORE AND AFTER TESTING THE EQUIPMENT. THIS VENTILATOR WILL BE TESTED, REPAIRED, AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    REPORTEDLY, VENTILATOR FAILED TO OPERATE IN THE AMBULANCE WHEN THE PT WAS BEING TRANSFERRED BETWEEN MEDICAL FACILITIES. THE VENTILATOR WAS TURNED ON AND THE MOTOR FAULT ERROR MESSAGE APPEARED AND ALARM SOUNDED. CONSEQUENTLY, THE VENTILATOR WAS NOT USED ON THE PT. THERE WAS NO BACK UP VENTILATOR IN THE AMBULANCE; THEREFORE, THE PT WAS MANUALLY VENTILATED DURING THE 60 MINUTE TRANSPORT. WHEN THE PT ARRIVED AT THE DESTINATION HOSP, SHE WAS TAKEN TO THE ER WHERE SHE WAS VENTILATED WITH THE HOSP EQUIPMENT. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT50-H1B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention