BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT WARMER

    MDR report key: 3885227 · Received June 19, 2014

    Report

    Report Number
    9611451-2014-00544
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 16, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695. METHOD: THE COMPLAINT PATIENT WARMER WAS RETURNED TO AN FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4) FOR ASSESSMENT AND REPAIR BY A TRAINED FPH TECHNICIAN. THE SUBJECT WARMER WAS MANUFACTURED IN 1999. RESULTS: DURING PERFORMANCE TESTING OF THE UNIT IT WAS FOUND THAT THE POWER FAIL ALARM WAS NOT WORKING. THE PROBLEM WAS TRACED TO AN ERROR ON THE UNIT'S POWER PCB BOARD. CONCLUSION: THE POWER FAIL ALARM ALERTS THE USER IN THE EVENT THAT POWER FAILS WHILE THE PATIENT WARMER IS SWITCHED ON. GIVEN THE AGE OF THE UNIT (FIFTEEN YEARS) THE FAILURE WAS PROBABLY DUE TO WEAR AND TEAR OF THE PCB COMPONENTS. THE PATIENT WARMER PRODUCT TECHNICAL MANUAL ADVISES THE USER TO "UNPLUG THE POWER CORD FROM THE WALL SUPPLY SOCKET" AND CHECK THAT THE POWER DISCONNECT (POWER FAIL) ALARM FUNCTIONS. THE SUPER CAPACITOR ON THE PCB BOARD CAN BE REPLACED AS REQUIRED. THE FAULTY COMPONENTS WERE REPLACED AND THE SUBJECT PW810 PATIENT WARMER WAS RETURNED TO THE CUSTOMER AFTER PASSING ALL THE NECESSARY SAFETY AND PERFORMANCE TESTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REQUESTED A PERFORMANCE CHECK OF A PW810 RADIANT PATIENT WARMER AND DURING SERVICING, IT WAS FOUND THAT THE POWER FAIL ALARM WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361088 PATIENT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD PW810

    Patients

    Seq Age Sex Outcome Treatment
    1