BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CITADEL BED FRAME

    MDR report key: 11320250 · Received February 12, 2021

    Report

    Report Number
    3007420694-2021-00015
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 15, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    UDI-DI
    05056097313726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A DEVICE INSPECTION, AN ARJO TECHNICIAN CONFIRMED THE REPORTED PROBLEM. THE DEFECTIVE CABLE WAS REPLACED AND THE BED PROPER FUNCTIONALITY WAS CONFIRMED DURING TESTING. THE INVESTIGATION PERFORMED BY THE MANUFACTURER REVEALED THAT THE DAMAGE WAS CAUSED BY THE INNER WIRE DETERIORATION DUE TO STRESS APPLIED DURING UP AND DOWN MOVEMENTS OF THE BED. THE INSTRUCTIONS FOR USE FOR THE CITADEL BED (830-213) INCLUDE THE FOLLOWING WARNINGS: ¿DISCONNECT THE BED FROM THE MAINS WALL OUTLET BEFORE STARTING ANY CLEANING OR MAINTENANCE ACTIVITY.¿ ¿DO NOT ALLOW THE MAINS PLUG OR POWER SUPPLY CORD TO GET WET WHEN CLEANING THE BED.¿ AS PER THE PREVENTIVE MAINTENANCE SECTION OF THE INSTRUCTIONS FOR USE FOR INDIGO (416260), THE INDIGO CABLES SHOULD BE EXAMINED FOR CUTS, ABRASIONS, KINKS OR OTHER DETERIORATION. WHEN ANY MALFUNCTION IS NOTICED, THE DEVICE SHOULD BE IMMEDIATELY WITHDRAWN FROM THE USE UNTIL THE SERVICE IS PERFORMED. TO SUM UP, THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE POWER SUPPLY CABLE MALFUNCTION RESULTED IN SPARKS. THIS COMPONENT WAS FOUND TO BE DAMAGED AND FROM THAT PERSPECTIVE, THE DEVICE DID NOT MEET PERFORMANCE SPECIFICATIONS. THE BED WAS IN USE WITH THE PATIENT FOR TREATMENT WHEN THE MALFUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE BED PERFORMED BY ARJO TECHNICIAN CONFIRMED THE PROBLEM OF THE DAMAGED POWER SUPPLY CABLE. THE RESULTS OF THE ANALYSIS WILL BE PROVIDED UPON CONCLUSIONS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PROCESS OF GATHERING INFORMATION IS ONGOING. THE RESULTS OF THE ANALYSIS WILL BE PROVIDED TO THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    FOLLOWING THE INFORMATION REPORTED, THE POWER SUPPLY CABLE FOR THE INDIGO MODULE (INTUITIVE DRIVE ASSIST) HAS CAUSED A SHORT CIRCUIT DURING ADJUSTING CITADEL BED HEIGHT. SPARKING FROM THE DAMAGED POWER SUPPLY CABLE WAS VISIBLE. WHEN THE FAILURE OCCURRED, THE PATIENT WAS REMOVED FROM THE BED IMMEDIATELY AND THE BED WAS QUARANTINED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222450 CITADEL BED FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. CXX21A6R4AMFA0 05056097313726

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other