BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1936602 · Received December 22, 2010

    Report

    Report Number
    9611451-2010-00778
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 26, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR850 HUMIDIFIER HAS BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTRE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE MR850 RESPIRATORY HUMIDIFIER WAS RECEIVED BY FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4) FOR EVALUATION. THE POWER CORD WAS VISUALLY INSPECTED FOR DAMAGE AND WAS TESTED FOR FUNCTIONALITY. RESULTS: THE PLUG ON THE POWER CORD WAS FOUND TO BE DISCOLORED. THERE WAS NO DAMAGE TO ANY OF THE WIRES IN THE POWER CORD AND NO PHYSICAL DAMAGE TO THE PLUG PINS. A LOT CHECK REVEALED NO OTHER COMPLAINTS RELATED TO DAMAGED OR BROKEN MR850 POWER CORDS FOR LOT NUMBER 030319 (MANUFACTURE DATE 19 MARCH 2003). CONCLUSION: THE PLUG ON THE POWER CORD WAS FOUND TO BE DISCOLORED, HOWEVER THERE WAS NO OTHER DAMAGE OR EVIDENCE OF BURNING. THE ROOT CAUSE OF THE DISCOLORATION COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE POWER CORD ON AN MR850 RESPIRATORY HUMIDIFIER "IS BURNED". NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE POWER CORD ON AN MR850 RESPIRATORY HUMIDIFIER "IS BURNED." NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR850AGU 030319

    Patients

    Seq Age Sex Outcome Treatment
    1