BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 5687520 · Received May 30, 2016

    Report

    Report Number
    9611451-2016-00237
    Event Type
    Malfunction
    Date Received
    May 30, 2016
    Report Date
    May 4, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR FROM THE HOSPITAL FACILITY. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTER IN (B)(4). IT WAS VISUALLY INSPECTED AND PERFORMACE TESTED, AS PER NEOPUFF INFANT RESUSCITATION TECHNICAL MANUAL, BY A QUALIFIED FPH SERVICE ENGINEER. OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT PROVIDED BY FPH SERVICE CENTER. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED NEOPUFF UNIT. PERFORMANCE CHECKS REVEALED THAT THE MANOMETER WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140909. CONCLUSION: 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 FAULT REPORTED BY THE HOSPITAL WAS NOT REPLICATED DURING PERFORMANCE CHECKS. NO FAULT WAS FOUND WITH THE SUBJECT NEOPUFF UNIT. ALL NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. 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 SUBJECT NEOPUFF WAS RETURNED TO THE HOSPITAL SERVICE AFTER THE PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE MANOMETER OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT PROVIDING ACCURATE READING. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE MANOMETER OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT PROVIDING ACCURATE READING. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342062 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1