BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE INFANT WARMER

    MDR report key: 1851071 · Received September 28, 2010

    Report

    Report Number
    9611451-2010-00590
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT UPPER HEAD CASING OF AN AN (B)(4) MOBILE INFANT WARMER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION, NOR WERE WE ABLE TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL WITH REGARD TO THE REPORTED PROBLEM. OUR INVESTIGATION IS BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS. RESULTS: WITHOUT THE COMPLAINT DEVICE WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED PROBLEM. CONCLUSION: CRAZING AND CRACKING OF THE UPPER HEAD CASING IS A KNOW PROBLEM AND USUALLY CAUSED BY INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC MATERIAL OF THE INFANT WARMER. IT CAN ALSO BE MECHANICALLY INDUCED RESULTING TO PHYSICAL DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE HEATER HEAD ASSEMBLY OF AN (B)(4) MOBILE INFANT WARMER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE'S (FPH) SERVICE ENGINEER IN OUR (B)(4) OFFICE THAT THE UPPER HEAD CASE OF AN (B)(4) MOBILE INFANT WARMER HAS CRACKED. THIS WAS OBSERVED AFTER USING ON A PT. NO PT 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

    Patients

    Seq Age Sex Outcome Treatment
    1