BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSMOTION MEDICAL, INC.

    MDR report key: 4279073 · Received November 20, 2014

    Report

    Report Number
    3004082462-2014-00003
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 23, 2014
    Report Date
    November 14, 2014
    Manufacturer
    TRANSMOTION MEDICAL INC.
    Product Code
    GBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) STATED A PRELIMINARY INVESTIGATION BY ADVOCATE BIOMED WAS COMPLETED AND FELT THE CHAIR WAS WORKING AS IT SHOULD. A TMM REPRESENTATIVE PROMPTLY REVIEWED THE EQUIPMENT ON 11/05/2014 AND A CONFIRMATORY INSPECTION BY ALSO FOUND IT TO BE IN GOOD WORKING CONDITION. AS THIS PT WAS UNATTENDED, IT IS NOT CLEARLY UNDERSTAND OF HOW THE PT WAS USING THE DEVICE. TMM CLEARLY STATES IN ALL OF OUR TRAINING MATERIALS THAT THE INGRESS/EGRESS PROTOCOL IS FROM THE SIDE, AND NOT THE FRONT. THIRD PARTY, (B)(4) LOAD TESTING VERIFIES THE SAFE AND EFFECTIVE STABILITY TESTING OF THE DEVICE.

    Description of Event or Problem · 1

    TMM NOTIFIED VIA VOICE MAIL ON (B)(6) 2014 BY (B)(4) THAT AN UNATTENDED ICU PT FELL OUT THE FRONT (FOOT SECTION) OF THE CHAIR. THE ROOT CAUSE WAS THE PT EGRESSED FROM THE FRONT THE DEVICE INSTEAD OF A SIDE INGRESS/EGRESS, WHICH IS STANDARD PROTOCOL. THE CHAIR TIPPED UP AND THE PT FELL ON THE FLOOR. EXACT CIRCUMSTANCES OF HOW THIS OCCURRED ARE UNK AS NO MEDICAL PERSONNEL WITNESS THE ADVERSE EVENT. ADVOCATE STATED THAT A SUBSEQUENT MEDICAL EVAL YIELDED NO SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753796 TRANSMOTION MEDICAL, INC. TMM4 MULTI-PURPOSE STRETCHER-CHARI GBB TRANSMOTION MEDICAL INC. TMM4BT 0757

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other