BEUDAMED
    FDA Adverse Event Summary report: N

    CITADEL

    MDR report key: 5849347 · Received August 5, 2016

    Report

    Report Number
    3007420694-2016-00167
    Date Received
    August 5, 2016
    Date of Event
    July 9, 2016
    Report Date
    July 9, 2016
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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). ARJOHUNTLEIGH RECEIVED A COMPLAINT ON CITADEL BED ON 2016-JUL-11 WITH REGARDS TO A PROBLEM CONCERNING THE EXIT ALARM FAILURE. THE ARJOHUNTLEIGH SERVICE TECHNICIAN WAS INFORMED BY THE REGISTERED NURSE - (B)(6), THAT DURING THE NIGHT SHIFT THE FEMALE PATIENT FELL OUT OF THE BED EVEN THOUGH ALL THE SIDE RAILS WERE IN RAISED POSITION, AND THE EXIT ALARM DID NOT ACTIVATE. INITIAL ASSESSMENT ENABLED US TO STATE THAT THE DEVICE WAS UP TO SPECIFICATION DURING THE EVENT SINCE THE DEVICE WAS CHECKED USING THE PROCESS DECK AND THE EXIT ALARM ACTIVATED WITHOUT ANY PROBLEM. THE FEMALE PATIENT THAT WEIGHED 80 LBS DID NOT SUSTAIN ANY INJURY AND NO INFORMATION OF SUCH HAS BEEN REPORTED TO ARJOHUNTLEIGH. LATER, ON 2016-JUL-11 ARJOHUNTLEIGH REPRESENTATIVE INFORMED THAT HE FOLLOWED UP WITH THE DAY SHIFT STAFF THIS MORNING AND WAS TOLD THAT THERE WAS NO FALL. A REVIEW OF STANDARD AND REPORTABLE COMPLAINTS WAS PERFORMED SHOWING THERE IS NO TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE FOR CITADEL BED FOR THESE KINDS OF EVENTS. THEREFORE THIS EVENT IS REGARDED AS A SINGLE EVENT. THE DEVICE DID NOT FAIL TO MEET SPECIFICATIONS SINCE THE ARJOHUNTLEIGH SERVICE TECHNICIAN WERE NOT ABLE TO RECREATE THE ISSUE WHILE PERFORMING THE ASSESSMENT AND THE POST-QC SHEET DOES NOT SHOW ANY MALFUNCTIONS FOUND. IN ACCORDANCE TO OUR BEST KNOWLEDGE PATIENT HAS NOT SUSTAINED ANY INJURY. IN THE EXTRACT FROM IFU 830 213 REV B (PLEASE SEE ATTACHED) WHICH IS SENT WITH EACH DEVICE THERE ARE PAGES REFERRING HOW TO SET UP AND OPERATE THE EXIT ALARM FUNCTION ON CITADEL BED. WHAT IS MORE THERE IS A NOTE ON PAGE 14 STATING; "THE BED IS NOT SUITABLE FOR PATIENTS UNDER 40 KGS (88 LBS) IN WEIGHT." INFORMATION ABOUT LATEST STAFF TRAINING PERFORMANCE WAS NOT DELIVERED THEREFORE WE CANNOT DISCARD USER ERROR WITH REGARDS TO PATIENT ASSESSMENT BEFORE USE THE CITADEL BED. IT IS RECOMMENDED THAT THE CUSTOMER SHOULD BE RETRAINED TO OPERATE THE EXIT ALARM ACCORDINGLY TO CITADEL BED IFU, AND REMINDED THAT THE ALARM CANNOT PREVENT BED EXIT, BUT IS ONLY THERE TO POINT IT OUT AFTER IT TAKES PLACE. NONE OTHER ACTIONS THAN THE ALREADY PERFORMED ARE REQUIRED. IN SUMMARY, GIVEN THE CIRCUMSTANCES THIS INCIDENT APPEARS TO BE A REMOTE ISSUE AND IN FACT A SINGLE EVENT SO FAR. OUR DEVICE - CITADEL BED - WERE USED WITH PATIENT WHEN THE INCIDENT TOOK PLACE, HOWEVER NO MALFUNCTIONS HAVE BEEN DETECTED ON THE DEVICE. WHAT IS MORE - NO INJURIES WERE REPORTED AND THERE ARE DIFFERENCES IN VERSIONS TOWARDS THE FALL TAKING PLACE. NEVETHERLESS, THE COMPLAINT IS DEEMED TO BE REPORTABLE DUE TO THE POSSIBLE OUTCOME OF THIS EVENT. THE TRAINING TO THE MEDICAL STAFF WILL BE SUGGESTED ON HOW TO USE VARIZONE EXIT ALARM AND THE CORRECT EVALUATION AND MONITORING OF THE PATIENT. WE ALSO SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    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). THE BED INVOLVED IN THE INCIDENT WAS RETURNED TO ARJOHUNTLEIGH SERVICE CENTER FOR EVALUATION. INITIAL ASSESSMENT ENABLE TO STATE THE DEVICE WAS UP TO SPECIFICATION DURING THE EVENT. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 0

    DURING THE ARJOHUNTLEIGH TECHNICIAN VISIT IN (B)(6) HOSPITAL ON (B)(6) 2016, HE WAS INFORMED BY THE RN - (B)(6), THAT DURING THE NIGHT SHIFT THE FEMALE PATIENT FELL OUT OF THE BED EVEN THOUGH ALL THE SIDE RAILS WERE IN RAISED POSITION, AND THE EXIT ALARM DID NOT ACTIVATE. MS. (B)(6) COMMENTED THAT THEY HAVE HAD ISSUES TRYING TO KEEP THE PATIENT IN THE BED, BUT STILL MAY CALL FOR ANOTHER ARJOHUNTLEIGH PRODUCT FOR THE PATIENT TO BE DELIVERED NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501520 CITADEL CYTADEL BED FRAME SYSTEM FNL ARJOHUNTLEIGH POLSKA SP. ZO.O. CX811A3F3AMAB0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other