BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2832626 · Received November 14, 2012

    Report

    Report Number
    9611451-2012-00823
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    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 RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4) WHERE IT WAS INSPECTED BY A TRAINED FPH TECHNICIAN. THE NEOPUFF WAS FITTED WITH A NEW VALVE AND FRONT PANEL ASSEMBLY, GIVEN A FULL PERFORMANCE CHECK AND RETURNED TO THE CUSTOMER TO BE PUT BACK INTO SERVICE. THE DEFECTIVE PARTS WERE SENT TO FPH (B)(4) FOR INVESTIGATION. RESULTS: VISUAL INSPECTION OF THE NEOPUFF REVEALED THAT THE GAS INLET PORT WAS BROKEN AND BOTH THE ENCLOSURE AND THE MANIFOLD WERE CRACKED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBER PROVIDED. CONCLUSION: THIS TYPE OF FAULT IS EASILY DETECTED WHEN THE NEOPUFF IS SET UP PRIOR TO PATIENT USE BECAUSE NO PRESSURE WILL BE INDICATED BY THE MANOMETER WHEN GAS IS SUPPLIED AT THE INLET PORT. 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. IT IS MOST LIKELY THAT THE PHYSICAL DAMAGE TO THE GAS INLET PORT AND ENCLOSURE WAS CAUSED BY SOME SORT OF IMPACT. WE CULD NOT DETERMINE HOW THE CENTRE MANIFOLD CAME TO BE BROKEN, BUT WE NOTE THAT THIS IS A TEN YEAR OLD DEVICE. 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE VALVE ON AN RD900 INFANT RESUSCITATOR WAS BROKEN AND THEY COULD NOT ADJUST THE MAXIMUM PRESSURE. THEY REQUESTED A REPAIR OF THE DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 021009

    Patients

    Seq Age Sex Outcome Treatment
    1