BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PATIENT CARE SYSTEM

    MDR report key: 7402089 · Received April 6, 2018

    Report

    Report Number
    3007420694-2018-00082
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Report Date
    May 16, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    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 10-MAR-2018 ARJO RECEIVED A CUSTOMER COMPLAINT INVOLVING CITADEL BED. THE REPORTED MALFUNCTION TOOK PLACE IN THE INSTITUTE FOR SURGICAL RESEARCH IN THE UNITED STATES. FOLLOWING THE INFORMATION PROVIDED, THE FACILITY STAFF WAS HAVING DIFFICULTY RESUSCITATING THE PATIENT DUE TOINOPERATIVE ELECTRICAL BED'S FUNCTIONS (INCLUDING ELECTRIC CPR). THE MANUAL CPR WAS USED INSTEAD OF ELECTRICAL FUNCTIONS IN ORDER TO REPOSITION THE PATIENT TO THE REQUIRED POSITION. THE PATIENT DID NOT SUSTAIN ANY INJURY. ALL MANUFACTURED CITADEL 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. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED FOR THIS SPECIFIC DEVICE AND NO ANOMALY WAS FOUND. EACH CITADEL BED IS EQUIPPED WITH MANUAL CPR RELEASE HANDLES LOCATED BELOW THE CALF SECTION ON EITHER SIDE OF THE BED AND ELECTRIC CPR BUTTONS BUILD UP IN CONTROL PANELS. THESE FEATURES FLATTEN THE MATTRESS PLATFORM TO THE HORIZONTAL POSITION TO ENABLE INTER ALIA INTUBATION TO BE CARRIED OUT. BASED ON THE PRODUCT DESIGN, EVEN THOUGH THE ELECTRIC CPR DOES NOT WORK THE MANUAL CPR CAN STILL BE USED TO ENABLE CARDIOPULMONARY RESUSCITATION TO BE PERFORMED. AT THE TIME THE MALFUNCTION OCCURRED THE BED WAS DISPLAYING AN ERROR E410 WHICH IS A GENERAL SERVICE ERROR INFORMING THAT THE BED REQUIRES TECHNICIAN INVESTIGATION. AFTER THE INCIDENT THE BED WAS INSPECTED BY ARJO TECHNICIAN WITH REGARDS TO THE ALLEGED ISSUE. THE TECHNICIAN WAS ABLE TO ELIMINATE ERROR THROUGHOUT CONDUCTING SOFTWARE RESET. THE EVALUATION REVEALED THAT THERE WAS NO MALFUNCTION FOUND WITHIN THE DEVICE. THE BED OPERATED AS INTENDED AND THE MALFUNCTION COULD NOT BE RECREATED AFTER RESET OF THE DEVICE ELECTRICAL FUNCTIONS. BASED ON ABOVE WE WERE NOT IN A POSITION TO DETERMINE THE EXACT CAUSE OF THE MALFUNCTION OCCURRENCE. ALTHOUGH THERE WERE NO INJURIES REPORTED, THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO ELECTRIC CPR BEING INOPERATIVE IN AN EMERGENCY SITUATION. AT THE TIME OF THE INCIDENT, THE BED WAS BEING USED FOR PATIENT CARE AND WAS NOT WORKING UP TO THE MANUFACTURER'S SPECIFICATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY (B)(4). THE INVESTIGATION CONCLUSIONS ARE STILL UNDER PREPARATION. THEY WILL BE PRESENTED IN A FINAL REPORT.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH WAS NOTIFIED ABOUT A COMPLAINT INVOLVING CITADEL BED. FOLLOWING THE INFORMATION REPORTED THE ELECTRIC CPR DID NOT WORK AT THE TIME THE PATIENT SUFFERED CARDIAC ARREST. THE MANUAL CPR WAS USED TO REPOSITION THE PATIENT TO REQUIRED POSITION. THE PATIENT WAS SUCCESSFULLY RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244958 CITADEL PATIENT CARE SYSTEM BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA CX811A3F3AMAB0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other