BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSMOTION MEDICAL, INC.

    MDR report key: 2460646 · Received February 16, 2012

    Report

    Report Number
    3004082462-2011-00001
    Event Type
    Other
    Date Received
    February 16, 2012
    Date of Event
    September 11, 2011
    Report Date
    December 16, 2011
    Product Code
    GBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT SERIAL NUMBER WAS UNK. UPON A DETAILED REVIEW AT THE FACILITY ON (B)(4) 2011, WITH THE RISK MGMT TEAM, DEPT MGR, AND TMM COO, IT WAS NOTED THAT THE PT WAS LEFT IN THE CHAIR FOR 1 - 1.5 HOURS WITH THE BACK SECTION UP, THE LEG SECTION UP, AND THE ARM RAILS UP. WHEN THE PT MOVED TO EXIT THE CHAIR FROM THE LEG SECTION, THE CHAIR TIPPED FORWARD. ESSENTIALLY THE PT SAT ON A PORTION OF THE CHAIR WHICH IS LABELED "WARNING: DO NOT STAND OR SIT ON FOOTREST." THE PT WAS ALSO NOT INFORMED OF HOW TO INGRESS/EGRESS. THE FACILITY DID NOT FILE A VOLUNTARY 3500 FORM AS THEY DIDN'T' SEE IT FIT THE REQUIREMENT. ULTIMATELY, THE RISK MGRS FELT THE ALLEGED INCIDENT WASN'T CREDIBLE ENOUGH TO WARRANT IT. A RE-INSERVICE OF THE PROPER INGRESS/EGRESS PROCEDURE WERE COMMUNICATED ON (B)(4) 2011. THE PT WAS LEFT ALONE IN THE CHAIR WITHOUT THE PROPER INSTRUCTION FOR INGRESS/EGRESS, NOR ANY ASSISTANCE WHEN SHE TRIED TO DO SO. THE STRETCHER-CHAIR WAS MISUSED, NOT DEFECTIVE.

    Description of Event or Problem · 1

    THE INITIAL REPORT WAS STATED AS: FEMALE PT IN THE EMERGENCY DEPT WAS ADMITTED ONTO ONE OF OUR TMM4 SERIES CHAIRS. SHE WAS PLACED IN BY THE STAFF AND WAS GOING TO NEED TO WAIT 1+ HOURS TO BE TREATED. SHE WAS LEFT IN HER TREATMENT ROOM WHILE AWAITING A PHYSICIAN. AT THIS POINT, SHE STATED THAT SHE ATTEMPTED TO "REPOSITION HERSELF," AND AT THIS TIME THE CHAIR TIPPED FORWARD. WHEN THE CHAIR TIPPED FORWARD, THE PT WAS INJURED DURING HER FALL. SHE REPORTED TO THE HOSP THAT SHE "RE-AGGRAVATED A SHOULDER INJURY," AS WELL AS HAD CONTUSIONS ON HER KNEE'S. ADDITIONALLY, SHE WAS EXPERIENCING NECK AND BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSMOTION MEDICAL, INC. TMM4 SERIES MULTI-PURPOSE STRETCHER/CHAI GBB TMM4-WB 2193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other