BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFLOW

    MDR report key: 2792332 · Received October 12, 2012

    Report

    Report Number
    2242551-2012-00002
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    January 3, 2011
    Report Date
    August 9, 2012
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    LGZ
    PMA / PMN Number
    K060537
    Removal / Correction Number
    2242551-06/15/11-005-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATA NOT CURRENTLY AVAILABLE. AS NO SERIAL NUMBER WAS PROVIDED, THE DEVICE MANUFACTURE DATE IS UNKNOWN. RECALL 2242551-06/15/11-005-R OF THE AFFECTED PRODUCT WAS INITIATED AND WAS REPORTED TO FDA PER 21 CFR PART 806 ON 06/15/2011. INVESTIGATION OF PREVIOUSLY REPORTED COMPLAINTS HAS SHOWN THAT THE SILICONE STRAP, BEDDING, TOWELS, OR DRAPES CAN ACT AS AN INSULATOR IN CONJUNCTION WITH THE RESTRICTED AIRFLOW WHEN THE DEVICE IS ATTACHED TO THE PATIENT. THIS CAUSES THE TEMPERATURE AT THE STRAP FACE, BEDDING, TOWEL OR DRAPE AND THE DEVICE BOTTOM TO RISE TO A TEMPERATURE GREATER THAN WHAT WOULD BE EXPERIENCED HAD THE DEVICE NOT BEEN ATTACHED TO THE PATIENT. THE PROLONGED PERIOD OF TIME, THE INFUSION WARMER WAS ATTACHED TO THE PATIENT, CAN CAUSE THE PATIENT BURN. THE WARMER IS DESIGNED TO BE PLACED ON THE BED OR ATTACHED TO A BED SHEET IN CLOSE PROXIMITY TO THE SITE OF INFUSION. THE WARMER IS NOT INTENDED TO BE AFFIXED DIRECTLY TO THE PATIENT FOR AN EXTENDED PERIOD OF TIME. THE SITE WAS NOTIFIED OF THE RECALL ON 10/24/2011 AND WAS PROVIDED A KIT THAT CONTAINS A WARNING LABEL TO ATTACH TO THE ENFLOW WARMER AND AN UPDATED OPERATOR'S MANUAL ON (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A BURN THAT INVOLVED AN ENFLOW FLUID WARMER. NO FURTHER INFORMATION WAS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENFLOW THERMAL INFUSION FLUID WARMER LGZ VITAL SIGNS, INC. 980105VS

    Patients

    Seq Age Sex Outcome Treatment
    1