BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARM AIR

    MDR report key: 1791665 · Received August 4, 2010

    Report

    Report Number
    1516825-2010-00008
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    October 16, 2007
    Report Date
    July 29, 2010
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Removal / Correction Number
    Z-0035-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT UNIT WAS SENT AND THE DEFECTIVE UNIT WAS RETURNED TO THE MFR FOR EVAL. THE EVAL RESULTS INDICATED IMPROPER SEATING OF MICROPROCESSOR BOARD CONNECTOR DURING ASSEMBLY, SERVICE, OR FIELD REPAIRS. THE INITIAL INVESTIGATION ALSO VERIFIED THAT THERE WAS NO FIRE AS A RESULT OF THE SMOKE. NOTE: IN RESPONSE TO THE WARNING LETTER (B)(4) SUB-ZERO REVIEWED ALL PRODUCT COMPLAINTS SINCE JANUARY 2007 AND IDENTIFIED THIS A REPORTABLE COMPLAINT THAT SHOULD HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WARM AIR 135 UNIT SMOKED, CAUGHT ON FIRE WHEN IT WAS TURNED ON THIS MORNING. THE FRONT FRAME MELTED AS A RESULT OF THIS. THE CUSTOMER ALSO STATED THE UNIT WAS WORKING FINE UNTIL LAST NIGHT WITH NO ISSUES. NO ONE WAS INJURED. THE UNIT WAS REMOVED FROM THE OPERATING ROOM IMMEDIATELY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARM AIR WARM AIR 135 DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 86186

    Patients

    Seq Age Sex Outcome Treatment
    1