BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2011221 · Received March 8, 2011

    Report

    Report Number
    9611451-2011-00134
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AEU HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. OUR ANALYSIS IS BASED ON THE SERVICE REPORT PROVIDED BY (B)(6) AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: (B)(6) REPORTED THAT THE FASCIA AND VALVE SYSTEM OF THE NEOPUFF UNIT WERE BROKEN. THE DEVICE WAS RETURNED INTO HOSPITAL SERVICE AFTER THE DEFECTIVE PARTS WERE REPLACED. CONCLUSION: THE NEOPUFF UNIT IS A PORTABLE REUSABLE DEVICE WHICH CAN BE SUSCEPTIBLE TO IMPACT DAMAGE. THE NEOPUFF TECHNICAL MANUAL PROVIDED WITH THE DEVICE 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.

    Description of Event or Problem · 1

    (B)(6) REPORTED THAT BOTH THE INLET AND OUTLET PORTS OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WERE BROKEN OFF. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1