BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PATIENT CARE SYSTEM

    MDR report key: 7536129 · Received May 23, 2018

    Report

    Report Number
    3007420694-2018-00111
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Report Date
    May 23, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O.O
    Product Code
    FNL
    UDI-DI
    05055982755764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ON 30-04-2018 ARJO HAS INITIALLY BECOME AWARE OF THE EVENT WITH THE INVOLVEMENT OF CITADEL MEDICAL BED WHICH OCCURRED IN (B)(6) HOSPITAL LOCATED IN (B)(6), USA. FOLLOWING THE INFORMATION REPORTED BY CUSTOMER WHILE THE PATIENT WAS LAYING ON A BED, THE MATTRESS STARTED TURNING UNINTENTIONALLY. THE ONE SIDE OF MATTRESS STARTED TO INFLATE ROTATING THE PATIENT TO ONE SIDE. AS A CONSEQUENCE OF THE EVENT PATIENT FALL FROM THE BED. THE PATIENT DID NOT SUSTAIN ANY INJURY. MOREOVER IT WAS REPORTED BY CAREGIVER THAT DURING THE EVENT THE PATIENT WAS SLEEPING NEAR THE BED EDGE. THE CUSTOMER ADVISED THAT THE SIDE RAILS WERE NOT IN RAISED POSITION AT THE TIME WHEN THE INCIDENT OCCURRED. POST PLACEMENT QUALITY CONTROL PERFORMED ON 30-APRIL-2018 DID NOT REVEAL ANY ANOMALOUS CONDITION, THE BED WAS WORKING AS INTENDED. SIDE RAILS ARE DESIGNED TO PREVENT UNINTENTIONAL EXITS/FALLS OF PASSIVE PATIENTS AND THE DECISION ON THEIR USAGE SHOULD BE BASED ON PATIENT'S CONDITION ASSESSMENT. THE ARJO SERVICE TECHNICIAN COULD NOT RE-CREATED THE REPORTED EVENT. NO MALFUNCTION WITH THE DEVICE WAS FOUND WHICH MIGHT LEAD TO UNINTENDED DEVICE MOVEMENT. DUE THIS FACT WE ARE UNABLE TO CONFIRM REPORTED CUSTOMER ALLEGATION. MOREOVER IFU FOR CITADEL (830.238 EN) CONTAINS SAFETY WARNINGS: " PRIOR TO ENGAGING ANY MATTRESS TO TURN FEATURE, MAKE SURE THAT ALL SIDE RAILS ARE FULLY ENGAGED IN THEIR FULL UPRIGHT AND LOCKED POSITION, DO NOT ACTIVATE THE TURNING FEATURE ON ANY MATTRESS SYSTEM WHEN PATIENT RESTRAINTS ARE IN USE." "WARNING: USE OR NON-USE OF RESTRAINTS, INCLUDING SIDE RAILS, CAN BE CRITICAL TO PATIENT SAFETY. SERIOUS OR FATAL INJURY CAN RESULT FROM THE USE (POTENTIAL ENTRAPMENT) OR NON -USE (POTENTIAL PATIENT FALLS) OF SIDE RAILS OR OTHER RESTRAINTS." THE REVIEW OF ALL REPORTABLE COMPLIANCE FOR LAST 5 YEARS SHOWED THAT THERE WAS NO SIMILAR EVENT FOUND RELATED TO UNINTENDED BED MOVEMENT. THIS CASE IS AN ISOLATED EVENT. TO CONCLUDE, ARJO CITADEL BED WAS USED FOR A PATIENT THERAPY WHEN THE PATIENT FELL OUT FROM THE BED ON THE FLOOR. THERE WAS NO TECHNICAL FAILURE FOUND WITH THE BED WHICH MIGHT HAVE CONTRIBUTED TO THE EVENT. THIS COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO PATIENT FALL. ALTHOUGH NO SERIOUS INJURY WAS SUSTAINED WE REPORTED THIS INCIDENT TAKING INTO ACCOUNT POTENTIAL FOR SERIOUS INJURY IF THIS SITUATION WILL REOCCUR.

    Description of Event or Problem · 0

    ON (B)(6) 2018 ARJO HAS INITIALLY BECOME AWARE OF THE EVENT WITH THE INVOLVEMENT OF CITADEL MEDICAL BED WHICH OCCURRED IN (B)(6) HOSPITAL LOCATED IN (B)(6), USA. FOLLOWING THE INFORMATION REPORTED BY CUSTOMER WHILE THE PATIENT WAS LAYING ON A BED, THE MATTRESS STARTED TURNING UNINTENTIONALLY. THE ONE SIDE OF MATTRESS STARTED TO INFLATE ROTATING THE PATIENT TO ONE SIDE. AS A CONSEQUENCE OF THE EVENT PATIENT FALL FROM THE BED. THE PATIENT DID NOT SUSTAIN ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379473 CITADEL PATIENT CARE SYSTEM BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP Z O.O CXB811A3F3AMAB0 05055982755764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other