BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATMOSAIR SAT

    MDR report key: 2846201 · Received November 20, 2012

    Report

    Report Number
    1625774-2012-00075
    Event Type
    Death
    Date Received
    November 20, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 30, 2012
    Manufacturer
    KCI USA, INC.
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 3, 2012, AFTER THE COMPLAINT INVESTIGATION, IT WAS DETERMINED THAT THE ATMOSAIR WITH SAT 9000 MRS WAS AN INTERNATIONAL ASSET AND WAS PURCHASED BY THE CUSTOMER IN 2003. THE SERIAL NUMBER OF THE UNIT ASSOCIATED WITH THIS COMPLAINT HAS NOT BEEN PROVIDED AND THEREFORE EVALUATION OF THE MATTRESS BY KCI QUALITY ENGINEERING COULD NOT BE PERFORMED. DEVICE LABELING INFORMATION AVAILABLE IN PRINT AND ONLINE STATES: ENSURE THERE ARE NO GAPS BETWEEN MATTRESS AND BED FRAME OR SIDE RAILS. BED FRAME - ALWAYS USE A STANDARD HEALTHCARE BED FRAME WITH THE MATTRESS, WITH ANY SAFEGUARDS OR PROTOCOLS THAT MAY BE APPROPRIATE. BED FRAME AND SIDE RAILS (IF USED) MUST BE PROPERLY SIZED RELATIVE TO THE MATTRESS TO HELP MINIMIZE ANY GAPS THAT MIGHT ENTRAP A PATIENT'S HEAD OR BODY. IT IS RECOMMENDED THAT BED AND SIDE RAILS (IF USED) COMPLY WITH ALL APPLICABLE REGULATIONS AND PROTOCOLS. MATTRESS INSTALLATION: POSITION MATTRESS ON BED FROM WITH LOGO FACING UP AND PRODUCT INFORMATION TAGS AT FOOT END OF BED; ENSURE THERE ARE NO GAPS BETWEEN THE MATTRESS AND BED FRAME OR SIDE RAILS. ALERT: ALWAYS USE A STANDARD HEALTHCARE BED FRAME WITH THE MATTRESS, WITH ANY SAFEGUARDS OR PROTOCOLS THAT MAY BE APPROPRIATE. BED FRAME AND SIDE RAILS (IF USED) MUST BE PROPERLY SIZED RELATIVE TO THE MATTRESS TO HELP MINIMIZE ANY GAPS THAT MIGHT ENTRAP A PATIENT'S HEAD OR BODY. SIDE RAILS/PATIENT RESTRAINTS - WHETHER AND HOW TO USE SIDE RAILS OR RESTRAINTS IS A DECISION THAT SHOULD BE BASED ON EACH PATIENT'S NEEDS AND SHOULD BE MADE BY THE PATIENT AND THE PATIENT'S FAMILY, PHYSICIAN AND CAREGIVERS, WITH FACILITY PROTOCOL IN MIND. CAREGIVERS SHOULD ASSESS RISKS AND BENEFITS OF SIDE RAIL/RESTRAINT USE (INCLUDING ENTRAPMENT AND PATIENT FALLS FROM THE BED) IN CONJUNCTION WITH INDIVIDUAL PATIENT NEEDS, AND SHOULD DISCUSS USE OR NON-USE WITH THE PATIENT AND/OR FAMILY. THIS INCLUDES ASSESSMENT OF THE BED OCCUPANT, AND THE COMBINATION OF BED FRAME, SIDE RAIL AND MATTRESS (OR MATTRESSES WHERE OVERLAYS ARE USED). RISK ASSESSMENT SHOULD BE REPEATED IF THE BED FRAME, SIDE RAILS OR CONDITION OF PATIENT CHANGES. CONSIDER NOT ONLY THE CLINICAL AND OTHER NEEDS OF THE PATIENT BUT ALSO THE RISK OF FATAL OR SERIOUS INJURY FROM FALLING OUT OF BED AND FROM PATIENT ENTRAPMENT.

    Description of Event or Problem · 1

    ON OCTOBER 30, 2012, THE FOLLOWING INFORMATION WAS REPORTED TO KCI FROM (B)(6) BY THE PHYSICIAN: ON (B)(6) 2012, THE PATIENT WAS FOUND UNRESPONSIVE BY THE NURSE WITH HIS HEAD AND RIGHT ARM ALLEGEDLY ENTRAPPED BETWEEN THE LOWER PART OF THE SIDE RAIL AND THE BED FRAME/ MATTRESS IN ZONE 5. THE PATIENT'S BODY AND LEFT ARM WERE POSITIONED OUTSIDE THE BED. IT WAS REPORTED THAT THE PATIENT DIED SHORTLY AFTER HE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATMOSAIR SAT IKY KCI USA, INC. 9000 MRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death