BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CITADEL PLUS

    MDR report key: 6562722 · Received May 12, 2017

    Report

    Report Number
    3007420694-2017-00113
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    March 31, 2017
    Report Date
    May 12, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O.O.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FIELD UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z.O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ON 12 APR 2017 ARJOHUNTLEIGH HAS RECEIVED A CUSTOMER COMPLAINT INVOLVING CITADEL PLUS BED (SERIAL NUMBER: (B)(6)) AND JOEMS OXFORD PRESENCE 227 HOIST (NON-ARJOHUNTLEIGH DEVICE). THE REPORTED MALFUNCTION TOOK PLACE IN (B)(6) HOSPITAL IN GREAT BRITAIN. IT NEEDS TO EMPHASIZE THAT THIS EVENT WAS DECIDED TO REPORTABLE TO THE COMPETENT AUTHORITIES DUE TO ARJOHUNTLEIGH DEVICE TAKING PART IN THE EVENT WHICH WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY UPON RECURRENCE, ALTHOUGH ARJOHUNTLEIGH DEVICE WAS NOT BEING THE CAUSE OF THE INCIDENT. FOLLOWING THE INFORMATION REPORTED, WHILE THREE STAFF MEMBERS (ONE QUALIFIED AND TWO HEALTHCARE SUPPORT WORKERS) WERE ATTEMPTING TO LOWER THE PATIENT BEING HOISTED ON JOEMS OXFORD PRESENCE 227 DEVICE WHICH IS NON-ARJOHUNTLEIGH PRODUCT ONTO CITADEL PLUS BED, THE HOIST SUDDENLY TILTED. THE STAFF MEMBER WAS TRYING TO SUPPORT THE PATIENT TO ENSURE PATIENT'S SAFETY. WHILE DOING SO, IT WAS REPORTED TO US THAT ONE STAFF MEMBER WAS HIT IN THE HEAD BY THE HOIST AND OTHER STAFF MEMBER SUSTAINED SOME FOOT INJURY. NURSE ADVISED THEM TO VISIT EMERGENCY DEPARTMENT, HOWEVER THE STAFF MEMBERS DECLINED AS INJURIES WERE NOT LASTING. NO FURTHER DETAILS WERE DISCLOSED. IN STAFF MEMBERS' OPINION THE HOIST TILTED DUE TO POWER DRIVE BOX (IN WHICH 5TH CASTOR IS PLACED) LOCATED UNDERNEATH THE BED AS THIS PREVENTED THEM TO POSITION THE HOIST CORRECTLY IN ORDER TO LOWER THE PATIENT SAFELY. THE NURSE WAS UNABLE TO CONFIRM NEITHER THE BRAKES OF THE HOIST WERE IN OPERATION WHILE THE INCIDENT OCCURRED NOR THE HOIST'S LEGS WERE SPLAYED. SHE CONFIRMED THAT TO HER KNOWLEDGE THE CORRECT SLING HAVE BEEN USED FOR PATIENT'S WEIGHT. AFTER THE INCIDENT, THE DEVICE WAS MOVED THROUGH THE ARJOHUNTLEIGH INSPECTION WHERE NO FAULT WAS FOUND WITHIN THE HOIST. LAST SERVICE RECORD OF THE HOIST WAS DATED ON 12 SEP 2016. ARJOHUNTLEIGH REPRESENTATIVE WAS NOT IN POSITION TO INSPECT THE BED INVOLVED IN THE INCIDENT AS THE DEVICE HAD NOT BEEN MADE AVAILABLE. TECHNICIAN CHECK OTHER DEVICE OF THE SAME TYPE AT THE FACILITY TO VERIFY CUSTOMER ALLEGATION. THE TECHNICIAN NOTICED THAT THE ONLY PLACE FOR LIFT TO STUMBLE WAS THE MOST LIKELY POWER DRIVE BOX LOCATED UNDER THE BED, HOWEVER AS THERE WAS NO PRODUCT FAILURE FOUND IT CAN BE ASSUMED THAT THE ISSUE WAS RELATED TO THE CAREGIVERS INADVERTENCY WHAT FURTHER RESULTED IN LIFT TILTING. LOOKING AT THE SEQUENCE OF EVENTS REPORTED, THIS PARTICULAR COMPLAINT IS CONSIDERED TO BE A SINGLE, ISOLATED EVENT, NO COMPLAINTS WERE FOUND CONCERNING THE SAME OR SIMILAR EVENT IN ARJOHUNTLEIGH COMPLAINT HANDLING SYSTEM. UPON THE COURSE OF THE INVESTIGATION WE WERE ABLE TO CONFIRM THAT ARJOHUNTLEIGH DEVICE WAS FOUND NOT TO HAVE MALFUNCTIONED (WAS PERFORMING UP TO THE SPECIFICATION) WHEN THE EVENT TOOK PLACE. ARJOHUNTLEIGH DEVICE WAS NOT BEING THE CAUSE OF THE INCIDENT. WHEN THE RESIDENT WAS BEING POSITIONED INTO ARJOHUNTLEIGH BED, USING NON ARJOHUNTLEIGH DEVICE - THE FLOOR LIFT TILTED SIDEWAYS AND INJURED THE CAREGIVERS. ARJOHUNTLEIGH DEVICE WAS NOT USED FOR A PATIENT THERAPY AND CARE. IT HAS BEEN DEEMED UNLIKELY THAT THE ARJOHUNTLEIGH BED COULD HAVE CONTRIBUTED TO THE CAREGIVER'S OUTCOME IN ANY WAY. H3 OTHER TEXT: DEVICE UNAVAILABLE FOR INSPECTION.

    Description of Event or Problem · 0

    ON 12 APR 2017 ARJOHUNTLEIGH HAS RECEIVED A CUSTOMER COMPLAINT INVOLVING CITADEL PLUS BED (SERIAL NUMBER: (B)(4)) AND JOEMS OXFORD PRESENCE 227 HOIST (NON-ARJOHUNTLEIGH DEVICE). THE REPORTED MALFUNCTION TOOK PLACE IN THE (B)(6) HOSPITAL IN (B)(6). IT NEEDS TO EMPHASIZE THAT THIS EVENT WAS DECIDED TO REPORTABLE TO THE COMPETENT AUTHORITIES DUE TO ARJOHUNTLEIGH DEVICE TAKING PART IN THE EVENT WHICH WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY UPON RECURRENCE, ALTHOUGH ARJOHUNTLEIGH DEVICE WAS NOT BEING THE CAUSE OF THE INCIDENT. FOLLOWING THE INFORMATION REPORTED, WHILE THREE STAFF MEMBERS (ONE QUALIFIED AND TWO HEALTHCARE SUPPORT WORKERS) WERE ATTEMPTING TO LOWER THE PATIENT BEING HOISTED ON JOEMS OXFORD PRESENCE 227 DEVICE WHICH IS NON-ARJOHUNTLEIGH PRODUCT ONTO CITADEL PLUS BED, THE HOIST SUDDENLY TILTED. THE STAFF MEMBER WAS TRYING TO SUPPORT THE PATIENT TO ENSURE PATIENT'S SAFETY. WHILE DOING SO, IT WAS REPORTED TO US THAT ONE STAFF MEMBER WAS HIT IN THE HEAD BY THE HOIST AND OTHER STAFF MEMBER SUSTAINED SOME FOOT INJURY. NURSE ADVISED THEM TO VISIT EMERGENCY DEPARTMENT, HOWEVER THE STAFF MEMBERS DECLINED AS INJURIES WERE NOT LASTING. NO FURTHER DETAILS WERE DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344593 CITADEL PLUS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP Z O.O. FXX21C4B1AAABB

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other