BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSEY BED 8070

    MDR report key: 7782318 · Received August 14, 2018

    Report

    Report Number
    2020362-2018-00058
    Event Type
    Injury
    Date Received
    August 14, 2018
    Report Date
    July 9, 2018
    Manufacturer
    TIDI PRODUCTS
    Product Code
    OYS
    PMA / PMN Number
    K113357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THIS REPORT IS BEING SUBMITTED PER FDA REQUEST A2, A4: NI H3: 81 (OTHER) - PRODUCT IS SCHEDULED TO BE RETURNED BUT HAVE NOT BEEN RECEIVED IN BY MANUFACTURING AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURING REFERENCE FILE #(B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED WHILE THE NURSE WAS ADJUSTING THE LINEN FOR THE PATIENT WITH HALF OF HER BODY INSIDE THE CANOPY, A NURSE TECH WAS STANDING ON THE OPPOSITE SIDE BEGAN TO MECHANICALLY RAISE THE BED AND A LOUD NOISE WAS HEARD FROM THE POSEY BED AS THE FOOT PORTION OF THE BED FELL AND HIT THE NURSE ON HIS HEAD AND SHOULDER. THE NURSE TECH WAS SENT TO ANTELOPE HOSPITAL FOR AN ASSESSMENT. THE PATIENT WAS REMOVED FROM THE POSEY BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624904 POSEY BED 8070 PATIENT BED WITH CANOPY/RESTRAINTS OYS TIDI PRODUCTS 8070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention