BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL AIRWAY TEMPERATURE PROBE

    MDR report key: 1203448 · Received October 17, 2008

    Report

    Report Number
    9611451-2008-00612
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K953392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED 900MR569 TEMPERATURE PROBE WAS CONNECTED TO AN MR730 HUMIDIFIER AND TEMPERATURE READINGS MONITORED OVER A PERIOD OF 1 HOUR. THE TEMPERATURE READINGS WERE VERIFIED AGAINST A DIGITAL THERMOMETER. RESULTS: NO PHYSICAL DAMAGE COULD BE DETECTED ON THE TEMPERATURE PROBE. A COMPARISON OF THE TEMPERATURE READINGS RECORDED ON THE HUMIDIFIER DISPLAY WITH THOSE OBTAINED FROM THE THERMOMETER INDICATE A VARIATION THAT IS WITHIN THE ACCEPTABLE RANGE FOR THIS DEVICE. A LOT CHECK REVEALED 1 OTHER COMPLAINT OF THIS NATURE FOR THIS PARTICULAR LOT NUMBER. CONCLUSION: NO FAULT HAS BEEN DETECTED WITH THE SUBJECT 900MR569 TEMPERATURE PROBE. THE DEVICE IS OPERATING CORRECTLY. WE HAVE RECEIVED 2 OTHER COMPLAINTS OF THIS NATURE IN RESPECT OF 2 OTHER DEVICES, ALL OF WHICH HAVE ORIGINATED FROM THE SAME HEALTHCARE FACILITY IN TAIWAN. THE MR730 RESPIRATORY HUMIDIFIER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR TESTING. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFO IN RESPECT OF THE HUMIDIFIER. A FOLLOW-UP VIGILANCE REPORT WILL BE PROVIDED WHEN ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN TAIWAN REPORTED VIA OUR DISTRIBUTOR THAT A 900MR569 AIRWAY TEMPERATURE PROBE CAUSED THE MR730 RESPIRATORY HUMIDIFIER TO HEAT CONTINUOUSLY "WITHOUT STOPPING." THE TEMPERATURE WITHIN THE HUMIDIFICATION CHAMBER WAS ALSO VERY HIGH. THIS EVENT WAS DETECTED BEFORE PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL AIRWAY TEMPERATURE PROBE BTT FISHER & PAYKEL HEALTHCARE, LTD. 900MR569 080108

    Patients

    Seq Age Sex Outcome Treatment
    1 MR730 RESPIRATORY HUMIDIFIER