BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE INFANT WARMER

    MDR report key: 1878005 · Received October 20, 2010

    Report

    Report Number
    9611451-2010-00633
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4). THE DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED WARMER ELEMENT WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: THE WARMER HEAD CASE WAS DELAMINATED AND WAS FLAKING ON THE BOTTOM EDGE. THE CASE WAS ALSO DISCOLORED AND HAD A BROWN STICKY RESIDUE ON IT. THE SCREW BOSS INSIDE OF THE CASE WAS BROKEN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 061019. CONCLUSION: THE DELAMINATION, FLAKING AND DISCOLORATION OF THE WARMER HEAD CASE IS CONSISTENT WITH DAMAGE CAUSED BY INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE (B)(4) COMPONENTS OF THE INFANT WARMER. THE INFANT WARMER SERVICE MANUAL FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS (B)(4) COMPONENTS AND STATES THE FOLLOWING: CAUTION: DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES HYPOCHLORITES, PEROXIDES, GLUTARALDEHYDE OR CLEANING PRODUCTS WITH A GREATER THAN 30% ALCOHOL BASE. CAUTION: THE CHEMICALS USED IN THESE PROPRIETARY CLEANING PRODUCTS MAY LEAD TO DISCOLOURATION, CRAZING AND EVENTUAL CRACKING OF THE HIGHLIGHTED PLASTIC SURFACES. OUR CLEANING INSTRUCTIONS RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES THAT CAN BE USED TO CLEAN THE FRONT PANEL FASCIAS AND OTHER HIGHLIGHTED WARMER COMPONENTS. THE CRACKED SCREW BOSS IS LIKELY TO BE RELATED TO ACCIDENTAL IMPACT DAMAGE OR DAMAGE CAUSED BY THE INCORRECT REMOVAL OF THE WARMER HEAD CASE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW910 INFANT WARMER HAD A CRACKED WARMER HEAD. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW910 INFANT WARMER HAD A CRACKED WARMER HEAD. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW910JEU 061019

    Patients

    Seq Age Sex Outcome Treatment
    1