BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 11830127 · Received May 16, 2021

    Report

    Report Number
    9611451-2021-00575
    Event Type
    Malfunction
    Date Received
    May 16, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 16, 2021
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RECEIVED BY FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. RESULTS: VISUAL INSPECTION OF THE DEVICE REVEALED THAT GLUE WAS EVIDENT IN THE BUNCHED SECTION OF THE SPRING AND OF THE MANIFOLD OF THE MANOMETER INLET PORT. CONCLUSION: IT IS POSSIBLE THAT THE TUBE MAY HAVE BEEN PULLED DUE TO EXCESSIVE FORCE. 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 IS ASSEMBLED AND 100% TESTED ON THE PRODUCTION LINE TO VERIFY THAT EACH NEOPUFF PRODUCT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS, INCLUDING THE VALVE ASSEMBLIES AND FLOW ADJUSTMENTS. 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".

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPH REVEALED THAT PVC TUBING DETACHED FROM THE MANIFOLD PORT. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. HOWEVER, IT IS POSSIBLE THAT THE TUBE MAY HAVE BEEN PULLED DUE TO EXCESSIVE FORCE. 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 IS ASSEMBLED AND 100% TESTED ON THE PRODUCTION LINE TO VERIFY THAT EACH NEOPUFF PRODUCT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS, INCLUDING THE VALVE ASSEMBLIES AND FLOW ADJUSTMENTS. 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".

    Description of Event or Problem · 0

    A DISTRIBUTOR IN WISCONSIN REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS NOT PROPERLY ATTACHED TO THE MANOMETER PORT OF THE VALVE ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN WISCONSIN REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS NOT PROPERLY ATTACHED TO THE MANOMETER PORT OF THE VALVE ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF FINALISING OUR INVESTIGATION FOR THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS NOT PROPERLY ATTACHED TO THE MANOMETER PORT OF THE VALVE ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726738 NEOPUFF INFANT RESUSCITATOR BTL BTL RD900 2101331074

    Patients

    Seq Age Sex Outcome Treatment
    1