BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1891564 · Received November 4, 2010

    Report

    Report Number
    9611451-2010-00678
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FISHER & PAYKEL HEALTHCARE REF: (B)(4) SERIAL NUMBER: (B)(4), LOT NUMBER: 100728, DATE OF MANUFACTURE: 07/28/2010. (B)(4), (B)(4), 100914, 09/14/2010. (B)(4), (B)(4), 100914, 09/14/2010. (B)(4), (B)(4), 100914, 09/14/2010. THE TECHNICAL MANUAL THAT WAS PROVIDED WITH THE FIVE COMPLAINT NEOPUFFS ADVISES THE USER TO "CHECK THAT THE GAUGE READS AT LEAST 60 CM H2O", NOT 65 CM H2O. THE CUSTOMER WAS ADVISED OF THIS SPECIFICATION AND ADVISED THAT FOUR OF THE FIVE COMPLAINT UNITS PASSED THIS TEST. ALTHOUGH THE CUSTOMER ADVISED THAT THERE WAS NO FAULT WITH THESE FOUR UNITS AS, ALL FIVE COMPLAINT DEVICES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4) FOR TESTING. THE FIVE NEOPUFFS WERE PERFORMANCE TESTED FOR FUNCTIONALITY BY FISHER & PAYKEL HEALTHCARE'S SERVICE TECHNICIANS. ALL FIVE UNITS WERE NEW WITH NO DAMAGE AND PASSED ALL FUNCTIONAL TESTS. NO FAULT WAS FOUND. THE NEOPUFFS WERE RETURNED TO THE CUSTOMER AND THE CUSTOMER WAS REMINDED OF THE PROPER TECHNICAL MANUAL TO REFERENCE FOR THESE DEVICES.

    Additional Manufacturer Narrative · 1

    FISHER & PAYKEL HEALTHCARE REF: (B)(4), SERIAL NUMBER: (B)(4), LOT NUMBER: 100728, DATE OF MANUFACTURE: 07/28/2010. FISHER & PAYKEL HEALTHCARE REF: (B)(4), SERIAL NUMBER: (B)(4), LOT NUMBER: 100914, DATE OF MANUFACTURE: 09/14/2010. FISHER & PAYKEL HEALTHCARE REF: (B)(4), SERIAL NUMBER: (B)(4), LOT NUMBER: 100914, DATE OF MANUFACTURE: 09/14/2010. FISHER & PAYKEL HEALTHCARE REF: (B)(4), SERIAL NUMBER: (B)(4), LOT NUMBER: 100914, DATE OF MANUFACTURE: 09/14/2010. FISHER & PAYKEL HEALTHCARE REF: (B)(4), SERIAL NUMBER: (B)(4), LOT NUMBER: 100914, DATE OF MANUFACTURE: 09/14/2010. TESTING. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT FIVE NEW RD900 NEOPUFF INFANT RESUSCITATORS FAILED THE INITIAL VALVE TEST. IT WAS REPORTED THAT THE MANOMETER NEEDLE WAS VIBRATING AND THAT FOUR OF THEM WOULD NOT REACH 65 CM H2O. IT WAS REPORTED THAT THE LAST UNIT WOULD NOT REACH 60 CM H2O. THE TESTING WAS CARRIED OUT PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT FIVE NEW RD900 NEOPUFF INFANT RESUSCITATORS FAILED THE INITIAL VALVE TEST. IT WAS REPORTED THAT THE MANOMETER NEEDLE WAS VIBRATING AND THAT FOUR OF THEM WOULD NOT REACH 65 CM H2O. IT WAS REPORTED THAT THE LAST UNIT WOULD NOT REACH 60 CM H2O. THE TESTING WAS CARRIED OUT PRIOR TO PATIENT USE.

    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