BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINUET2 RANGE

    MDR report key: 2020150 · Received March 9, 2011

    Report

    Report Number
    3003984900-2011-00007
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HAS BEEN CAUSED BY THE MAINS CABLE HAS BEEN SEMI SHEARED BY BEING ALLOWED TO BECOME TRAPPED IN THE CENTRAL LOCATING BRACKETS OF THE SELF ASSEMBLY BED, ALTHOUGH THERE ARE SEVERAL WARNINGS WITHIN THE USER MANUAL ((B)(4). FEB2010) TO ENSURE THE CORRECT LOCATION OF THE CABLES IN THE CHANNEL PROVIDED: ON PAGE 2 IN THE GENERAL WARNINGS, CAUTIONS AND NOTES SECTION: "ELECTRICAL EQUIPMENT CAN BE HAZARDOUS IF MISUSED." "ENSURE THAT THE BED IS ASSEMBLED AND INSTALLED IN ACCORDANCE WITH THE INSTRUCTIONS GIVEN IN THIS USER MANUAL." ON PAGE 3 - CAUTION STATEMENT: "TAKE CARE TO ENSURE THAT THE MAINS CABLE IS NOT DAMAGED BY THE BED OR OTHER OBJECTS BEING MOVED OVER IT." IN CHAPTER 3 - ASSEMBLY & INSTALLATION, PAGES 7 TO 15 COVER ASSEMBLY OF THE BED AND CABLE POSITIONS. THE MANUFACTURER CONCLUDES THAT USER ERROR DURING SET-UP AND INSTALLATION CAUSED THE INCIDENT. ARJOHUNTLEIGH RECOMMENDS THAT THE FACILITY RETRAIN RELEVANT EMPLOYEES ON THE USER MANUAL AND ON THE WARNINGS AND PROPER INSTALLATION INSTRUCTIONS STATED WITHIN.

    Description of Event or Problem · 1

    WE HAVE BEEN MADE AWARE OF AN INCIDENT BY THE ARJOHUNTLEIGH SERVICE ENGINEER THAT WAS ATTENDING THE CUSTOMER SITE FOR A REPAIR TO THE BED. WHILE ON SITE REPAIRING THE BED, IT WAS NOTICED THAT THE MAINS CABLE HAD NOT BEEN CORRECTLY FED THROUGH THE PROPER CHANNEL CAUSING THE CABLE TO BECOME TRAPPED IN THE CENTRAL LOCATING BRACKETS. THE ENGINEER IMMEDIATELY REMOVED THE CABLE, NOTIFIED THE RELEVANT STAFF AND INFORMED THEM NOT TO USE THE BED. THE CABLE HAD BEEN DAMAGED EXPOSING THE ELECTRICAL WIRES. THE SITE USERS HAVE REPORTED THAT THE BED HAD BEEN BUILT BY THEIR OWN ESTATES DEPARTMENT; THEY TOOK PHOTOS OF THE CABLES AND LOGGED IT AS AN INCIDENT INTERNALLY. THE BED HAS BEEN REMOVED FROM SERVICE PENDING INVESTIGATION AND REPAIR. NO INJURIES HAVE BEEN REPORTED AND THERE WAS NO INDICATION THAT THERE WAS A PATIENT ON THE BED DURING THE SERVICE ENGINEER'S VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINUET2 RANGE BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH 161A-MOD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other