BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 5674693 · Received May 23, 2016

    Report

    Report Number
    9611451-2016-00227
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Report Date
    April 25, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FASCIA AND VALVE SYSTEM OF THE COMPLAINT RD900AFU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS OUTLET PORT OF THE SUBJECT NEOPUFF UNIT WAS BROKEN, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 080520. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANT 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 PHYSICAL DAMAGE OBSERVED WAS MOST LIKELY DUE TO IMPACT TO THE SUBJECT NEOPUFF UNIT. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF 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." EACH NEOPUFF UNIT IS ASSEMBLED AND 100% TESTED IN THE PRODUCTION LINE TO VERIFY THAT EACH UNIT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ANY UNIT THAT FAILS IS REJECTED. THIS SUGGESTS THAT THE SUBJECT NEOPUFF UNIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE SUBJECT NEOPUFF UNIT WAS REPAIRED AND RETURNED TO HEALTHCARE FACILITY SERVICE AFTER PASSING THE PERFORMANCE CHECKS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RD900AFU NEOPUFF INFANT RESUSCITATOR FROM THE HEALTHCARE FACILITY. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF AN RD900AFU NEOPUFF INFANT RESUSCITATOR WAS FOUND BROKEN DURING THEIR ANNUAL PREVENTIVE MAINTENANCE CHECK.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF AN RD900AFU NEOPUFF INFANT RESUSCITATOR WAS FOUND BROKEN DURING THEIR ANNUAL PREVENTIVE MAINTENANCE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325773 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AFU

    Patients

    Seq Age Sex Outcome Treatment
    1