BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 4299145 · Received December 4, 2014

    Report

    Report Number
    9611451-2014-00888
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 20, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF WAS RECEIVED AT OUR REGIONAL OFFICE IN (B)(4), WHERE IT WAS INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. OUR INVESTIGATION IS BASED ON PHOTOGRAPHS AND INFORMATION PROVIDED BY OUR CHINESE OFFICE. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPHS OF THE SUBJECT NEOPUFF REVEALED THAT THE TUBE FROM THE MANIFOLD HAS LOOSENED FROM THE MANOMETER. A REVIEW OF THE COMPLAINT NEOPUFF'S PRODUCTION TEST RECORD REVEALED THAT THE UNIT HAD PASSED ALL FUNCTIONAL TESTING AT THE TIME OF MANUFACTURE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR A DETACHED TUBING FOR LOT 140527. CONCLUSION: THE NEOPUFF IS ASSEMBLED AND 100% TESTED ON THE PRODUCTION LINE TO VERIFY THAT EACH NEOPUFF PRODUCT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF / PERIVENT INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT". IN ADDITION THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". THE NEOPUFF WAS REPAIRED BY THE CHINESE FISHER & PAYKEL HEALTHCARE SERVICE CENTRE AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR DID NOT PROVIDE PRESSURE WHEN CONNECTED TO THE GAS SUPPLY AND THAT THE MANOMETER WAS FOUND TO BE NOT CONNECTED TO THE GAS TUBE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785047 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 140527

    Patients

    Seq Age Sex Outcome Treatment
    1