BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN ADVANCE TABLE

    MDR report key: 11901628 · Received May 28, 2021

    Report

    Report Number
    3010216206-2021-00003
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    January 20, 2021
    Report Date
    May 28, 2021
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    GDC
    UDI-DI
    00615521003104
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION BY A HILLROM TECHNICIAN IDENTIFIED THAT THE MALFUNCTION WAS DUE TO THE DEVICE HAVING A FAULTY INDICATOR PCB. THIS COMPONENT WAS REPLACED BY THE HILLROM TECHNICIAN. THE TABLE IS INTENDED TO BE USED IN AN OPERATING ROOM ENVIRONMENT TO SUPPORT AND POSITION PATIENTS DURING SURGICAL PROCEDURES. SEVERAL TYPES OF SPECIALTY TOPS CAN BE ATTACHED TO THE TABLE TO PERMIT SURGICAL ACCESS AND 360° RADIOLUCENCY FOR VARIOUS TYPES OF SURGICAL OPERATIONS. THE PATIENT CAN BE SECURED INTO VARIOUS OPERABLE POSITIONS FROM THE SUPINE, PRONE, OR LATERAL POSITION. ELECTRONIC CONTROLS ON THE TABLE PENDANT PERMIT THE ADJUSTMENT OF TABLE HEIGHT, ANGLE, TILT, AND AUXILIARY FUNCTION FOR THE LATERAL TOP. THE TABLE CONTAINS ELECTRONIC LOCKING CASTERS THAT PERMIT THE TABLE TO BE MOVED AND LOCKED INTO POSITION BY USE OF AN ELECTRONIC CONTROL ON THE TABLE PENDANT. THE DEVICE USER MANUAL INSTRUCTS THAT "BEFORE EACH USE OF THE TABLE, MAKE SURE ALL NECESSARY ACCESSORIES ARE ATTACHED AND THE TABLE IS READY FOR USE. IF ANY OF THE CONTROLS OR INDICATORS DO NOT OPERATE CORRECTLY, DO NOT USE THE TABLE. CONTACT ALLEN MEDICAL OR YOUR LOCAL DISTRIBUTOR." THERE WAS NO REPORT OF INJURY TO THE PATIENT. IT IS NOTED THAT THE SURGICAL PROCEDURE WAS DELAYED FOR GREATER THAN AN HOUR DURING TROUBLESHOOTING OF THE DEVICE AND THE SUBSEQUENT TRANSFER OF THE PATIENT TO A BACKUP DEVICE. ALTHOUGH THIS EVENT DID NOT RESULT IN PATIENT INJURY, IF THE REPORTED EVENT WERE TO RECUR, A SERIOUS INJURY COULD OCCUR BASED ON THE RISKS ASSOCIATED WITH A SIGNIFICANT DELAY IN SURGICAL PROCEDURE AND THE TRANSFER OF THE PATIENT. THEREFORE, HILLROM CONSIDERS THIS A REPORTABLE ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE ALLEN ADVANCE TABLE WOULD NOT MOVE, THE LIGHTS ON THE TOP COLUMN WERE NOT SHOWING, THERE WERE NO FUNCTIONS VIA THE PENDANT, AND THE BED REMAINED UNLOCKED. AT THE CUSTOMER'S REQUEST A HILLROM REPRESENTATIVE ATTENDED THE CUSTOMER SITE AND ATTEMPTED TO RESOLVE THE ISSUE, HOWEVER THEY WERE UNABLE TO SUCCESSFULLY GET THE DEVICE TO FUNCTION CORRECTLY. FOLLOWING THE UNSUCCESSFUL ATTEMPT TO REPAIR THE DEVICE, THE PATIENT WAS TRANSFERRED TO A BACKUP TABLE FOR COMPLETION OF THE SURGICAL PROCEDURE. THIS RESULTED IN A DELAY OF GREATER THAN 1 HOUR TO THE SURGICAL PROCEDURE. SUBSEQUENTLY, THE CUSTOMER CONFIRMED THAT THEY HAD EXPERIENCED A SIMILAR ISSUE WITH THE SAME DEVICE A WEEK PRIOR TO THIS INCIDENT BUT THAT THE ISSUE HAD BEEN SOLVED WHEN THE CUSTOMER PULLED THE EMERGENCY BRAKES AND TURNED THE TABLE OFF. THERE WAS NO REPORTED INJURY TO THE AFFECTED PATIENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800441 ALLEN ADVANCE TABLE TABLE, OPERATING-ROOM, ELECTRICAL GDC ALLEN MEDICAL SYSTEMS A-71101-UK 00615521003104

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization