BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 20547834 · Received October 28, 2024

    Report

    Report Number
    9611451-2024-00770
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 25, 2024
    Report Date
    September 29, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    UDI-DI
    09420012412201
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: RD900AZU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA, RD900AEU. THE 510(K) FOR THAT PRODUCT IS K971695. FISHER & PAYKEL HEALTHCARE (F&P) IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: RD900AZU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA, RD900AEU. THE 510(K) FOR THAT PRODUCT IS K971695 METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO THE FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN CHINA, WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. RESULTS: INSPECTION OF THE RD900 NEOPUFF INFANT RESUSCITATOR REVEALED THAT THE GAS OUTLET WAS BROKEN. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. HOWEVER, THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS DUE TO PHYSICAL IMPACT. 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 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. 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". AS MENTIONED, 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. 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. THE SUBJECT NEOPUFF WOULD HAVE MET THE REQUIREMENTS AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN CHINA REPORTED THAT THE GAS OUTLET PORT OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN CHINA REPORTED THAT THE GAS OUTLET PORT OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965367 FISHER & PAYKEL HEALTHCARE INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900AZU 140416 09420012412201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown