BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRWAY TEMPERATURE PROBE

    MDR report key: 1544923 · Received November 6, 2009

    Report

    Report Number
    9611451-2009-00589
    Event Type
    Malfunction
    Date Received
    November 6, 2009
    Report Date
    October 9, 2009
    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

    (B)(4). THE DEVICE IS CURRENTLY EN ROUTE TO THE MANUFACTURER FOR INSPECTION. THE LOT NUMBERS OF THE DEVICES INVOLVED WERE: 081218 AND 090226. THE DEVICE MANUFACTURE DATES OF THE DEVICES INVOLVED WERE: 12/18/08 AND 02/26/09. WE WILL PROVIDE A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT A QUANTITY OF 7 900MR569 AIRWAY TEMPERATURE PROBES COULD NOT SENSOR THE RIGHT TEMPERATURE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRWAY TEMPERATURE PROBE BTT FISHER & PAYKEL HEALTHCARE LTD. 900MR569 081030

    Patients

    Seq Age Sex Outcome Treatment
    1