BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 4472543 · Received February 1, 2015

    Report

    Report Number
    9611451-2015-00039
    Event Type
    Malfunction
    Date Received
    February 1, 2015
    Report Date
    January 20, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF WAS RECEIVED AT OUR REGIONAL OFFICE IN (B)(6), WHERE IT WAS INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. OUR INVESTIGATION IS BASED ON PHOTOGRAPHS AND INFORMATION PROVIDED BY OUR (B)(4) OFFICE. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPHS OF THE SUBJECT NEOPUFF REVEALED THAT THE GAS OUTLET PORT AND THE UPPER END CAP WERE CRACKED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 090317. CONCLUSION: THE NATURE OF THE CRACKING SUGGESTS THAT THE DEVICE HAS SUSTAINED SOME FORM OF IMPACT DAMAGE. THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING A PORTABLE DEVICE, THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. 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". THE NEOPUFF WAS REPAIRED BY THE (B)(6) FISHER & PAYKEL HEALTHCARE SERVICE CENTRE AND RETURNED TO THE CUSTOMER AFTER PASSING THE SAFETY AND PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR HAD A BROKEN GAS OUTLET CONNECTOR AND REQUESTED A REPAIR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73379 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 090317

    Patients

    Seq Age Sex Outcome Treatment
    1