BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 1161385 · Received September 12, 2008

    Report

    Report Number
    2936999-2008-00406
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    COVIDIEN / FORMERLY TYCO HEATHCARE
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARMTOUCH 5300 PATIENT WARMER HAS BEEN DISCONTINUED, AND IS BEING REPLACED WITH A NEW DESIGNED WARMTOUCH PATIENT WARMER. ACTIVE CUSTOMERS HAVE BEEN NOTIFIED OF THE AVAILABILITY OF THE NEW 5300A MODEL WHICH ADDRESSES THE POTENTIAL FAILURE MODE. NELLCOR PURITAN BENNETT HAS REQUESTED THE CUSTOMER RETURN THIS UNIT FOR EVALUATION. IF THE DEVICE IS RETURNED, AND SIGNIFICANT NEW INFORMATION RESULTS, A SUPPLEMENTAL WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CALLER STATED THE WARMTOUCH UNIT OVERHEATED AND BEGAN TO SMOKE. THE CALLER DID NOT KNOW THE TEMPERATURE SETTING OF THE UNIT DURING THE EVENT, HOW LONG IT HAD BEEN LEFT ON, OR WHEN PREVENTATIVE MAINTENANCE OR FILTER REPLACEMENT WAS DONE. THERE WAS NO PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMTOUCH COMPACT WARMING UNIT CONVECTIVE AIR WARMER DWJ COVIDIEN / FORMERLY TYCO HEATHCARE 5300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention