BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 5321289 · Received December 22, 2015

    Report

    Report Number
    9611451-2015-00560
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Report Date
    November 30, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RECENTLY RETURNED TO OUR SERVICE CENTRE IN (B)(4). OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR SERVICE CENTRE IN (B)(4) WHERE IT WAS INSPECTED AND PERFORMANCE TESTED BY A TRAINED FISHER & PAYKEL HEALTHCARE (FPH) SERVICE TECHNICIAN. OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT PROVIDED BY THE FPH SERVICE CENTRE. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE FRONT CASING AND UPPER AND LOWER END CAPS. THE PERFORMANCE TEST REVEALED THAT THE REPORTED FAULT COULD NOT BE REPLICATED WITH REGARDS TO THE FLUCTUATING MANOMETER NEEDLE. THE UNIT PASSED ALL CONDUCTED PERFORMANCE TESTS AND THE NEEDLE WAS OBSERVED TO MOVE SMOOTHLY WITHOUT RANDOM FLUCTUATIONS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140728. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE MANOMETER NEEDLE TO "FLUCTUATE ONCE THE PRESSURE INCREASES AT 20CM H20 WITH THE BLEED VALVE CLOSED" AS NO FAULT WAS FOUND WITH THE COMPLAINT DEVICE RECEIVED. 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 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 MANOMETER WITH A NEEDLE THAT FLUCTUATES ONCE THE PRESSURE INCREASES AT 20CM H20 WITH THE BLEED VALVE CLOSED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR HAD A MANOMETER WITH A NEEDLE THAT "FLUCTUATES ONCE THE PRESSURE INCREASES AT 20CM H20 WITH THE BLEED VALVE CLOSED". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845735 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 140728

    Patients

    Seq Age Sex Outcome Treatment
    1