BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PLUS

    MDR report key: 6954263 · Received October 17, 2017

    Report

    Report Number
    3007420694-2017-00208
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 26, 2017
    Report Date
    November 29, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    SERVICE PERSONNEL

    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). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    DURING THE BED PRESENTATION TO THE CUSTOMER (B)(6) ARJOHUNTLEIGH SERVICE TECHNICIAN NOTICED THAT THE CITADEL PLUS BED MOVED INTO 'AUTO-CHAIR-DOWN' POSITION WHILE 'AUTO-CHAIR' BUTTON WAS PRESSED. THERE WAS NO INJURY SUSTAINED AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH (B)(4) REGISTRATION# (B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) REGISTRATION# (B)(4). THE ARJOHUNTLEIGH CITADEL PLUS BARIATRIC CARE SYSTEM IS INTENDED FOR THE ACUTE AND POST-ACUTE CARE ENVIRONMENTS. IT IS INDICATED FOR MEDICAL PURPOSES TO AID THE PATIENT AND STUFF DURING THE PERFORMANCE OF ROUTINE CARE. ONE OF THE FEATURES OF THIS BED IS 'AUTO-CHAIR' FUNCTION WHICH SIMULTANEOUSLY RAISES THE BACKREST AND THIGH SECTIONS OF THE BED, PAUSING WHEN THE BACKREST REACHES 45 DEGREES. 'AUTO-CHAIR DOWN' BUTTON RETURNS THE DECK TO A FLAT AND LEVEL POSITION. ON (B)(6) 2017 ARJOHUNTLEIGH WAS NOTIFIED ABOUT AN CUSTOMER COMPLAINT INVOLVING CITADEL PLUS BED. THE REPORTED MALFUNCTION TOOK PLACE IN THE (B)(6) CUSTOMER FACILITY IN (B)(6). FOLLOWING THE INFORMATION REPORTED THE BED MOVED IN REVERSE DIRECTION THEN COMMENDED TO. WHILE 'AUTO-CHAIR' FUNCTION WAS ACTIVATED THE DEVICE MOVED INTO 'AUTO-CHAIR-DOWN' POSITION. THE RESIDENT DID NOT SUSTAIN ANY INJURIES RESULTING FROM THE REPORTED UNINTENDED BED MOVEMENT. IT NEEDS TO BE EMPHASIZED THAT ALL MANUFACTURED CITADEL PLUS BEDS ARE CHECKED BEFORE BEING DISTRIBUTED TO THE CUSTOMERS TO VERIFY IF THE PRODUCT MEETS THE REQUIRED MANUFACTURER'S SPECIFICATIONS AND CHECK WHETHER THE ACCEPTANCE CRITERIA ARE MET. RECORDS OF THE INSPECTION ARE DOCUMENTED IN THE DEVICE HISTORY RECORD (DHR). THE DEVICE HISTORY RECORD HAS BEEN REVIEWED FOR THIS SPECIFIC DEVICE AND NO ANOMALY WAS FOUND. THE BED IN QUESTION WAS A RENTAL ASSET, NOT THE CUSTOMER OWNED. THERE WAS NO PREVIOUS PREVENTIVE MAINTENANCE PERFORMED ON THAT BED AS THE DEVICE WAS BRAND NEW AND DID NOT EXCEED THE AGE OF ONE YEAR. AFTER THE UNCOMMANDED MOVEMENT OCCURRENCE THE BED WAS THEN TAKEN TO THE SERVICE CENTER FOR THE EVALUATION. THE INSPECTION DONE BY ARJOHUNTLEIGH TECHNICIAN REVEALED THAT ALL BED FUNCTIONS OPERATED AS INTENDED AND NO SERVICE WAS REQUIRED. AS THE REVERSE MOVEMENT OF THE BED COULD NOT BE DUPLICATED AND THE BED WAS FULLY OPERATIONAL AND UP TO THE MANUFACTURER'S SPECIFICATION, WE WERE NOT ABLE TO IDENTIFY THE CAUSE OF THE MALFUNCTION REPORTED. ALTHOUGH THERE WERE NO INJURIES REPORTED, THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE ALLEGATION OF THE UNCOMMANDED BED MOVEMENT OCCURRENCE. IT REMAINED UNKNOWN IF THE DEVICE WAS BEING USED FOR PATIENT HANDLING AT THE TIME THE BED MOVED IN THE REVERSE DIRECTION THAN COMMANDED TO. UPON THE CONDUCTED INVESTIGATION AND BED INSPECTION DONE BY THE ARJOHUNTLEIGH REPRESENTATIVE, WE WERE UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF CLAIMED FAILURE. THE REPORTED MALFUNCTION COULD NOT BE RECREATED DURING INSPECTION IN SERVICE CENTER AND NO FAULT WAS FOUND WITHIN THE DEVICE AT THAT TIME. THE DEVICE WAS REPORTED TO MOVE IN A DIFFERENT DIRECTION THAN INTENDED TO AND FROM THAT PERSPECTIVE, THE CITADEL PLUS BED DID NOT MEET ITS PERFORMANCE SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735467 CITADEL PLUS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. FXX21C4D4AKDBB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other