BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINUET 2

    MDR report key: 2163484 · Received June 27, 2011

    Report

    Report Number
    3003984900-2011-00017
    Event Type
    Other
    Date Received
    June 27, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 28, 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 PT'S MOTHER ADVISED THE ARJOHUNTLEIGH REP THAT HER SON WAS VERY SENSITIVE TO HIS WEIGHT AND THAT SHE DIDN'T KNOW HIS CURRENT WEIGHT (WHEN HE ORIGINALLY GOT THE BED FRAME APPROX (B)(6) MONTHS AGO HIS WEIGHT WAS (B)(6), BUT THAT HE WOULD BE A LOT HEAVIER NOW). SHE ALSO SAID THAT AFTER THE BED FRAME HAD COLLAPSED, HER SON SAID THAT IT HAD BEEN FEELING MORE UNSTABLE RECENTLY; SHE ADDED THAT HER SON WOULD MOVE AROUND A LOT IN THE BED DURING THE NIGHT AND CONFIRMED THAT HE WOULD SIT ON THE SIDE OF THE BED FRAME - IT WAS NOTED THAT THERE IS A TV TO THE SIDE OF THE BED FRAME. IT HAS NOW BEEN ESTABLISHED THAT THE PT'S WEIGHT WAS (B)(6), (B)(6) MONTHS AGO ((B)(6)) WHICH MEANS THE PT SHOULD NOT HAVE BEEN USING THE MINUET2 AS THE SWL IS ONLY (B)(6). THIS MEANS THAT THE BED WAS OVER-LOADED BY AT LEAST (B)(6), BUT THIS DOES NOT TAKE INTO ACCOUNT THE MATTRESS WEIGHT AND BED CLOTHS, MAKING THE TOTAL OVER-LOAD APPROX (B)(6) OVER THE SWL. ALTHOUGH THE SWL HAS CLEARLY BEEN EXCEEDED WE ARE HAVING THE BED FRAME SHIPPED TO OUR (B)(4) FACILITY FOR FURTHER INVESTIGATION TO ENSURE OVERLOAD IS THE PRIMARY CAUSE. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS LYING ON THE MINUET 2 BED FRAME DURING THE NIGHT WHEN IT SUDDENLY COLLAPSED. HIS MOTHER HEARD THE CRASH AND WHEN SHE CAME TO CHECK ON HIM, SHE FOUND THAT THE BED FRAME WAS LYING TO ONE SIDE, THE BACKREST ACTUATOR WAS SMASHED WITH THE WORM DRIVE HANGING OUT. THE MOUNTING POINTS FOR THE BACKREST ACTUATOR WERE COMPLETELY BENT AROUND. ONE OF THE SUPPORT PINS ON THE BACKREST WAS MISSING. THE HEAD AND FOOT BOARD MAIN SUPPORT TUBING HAS SHEARED OFF ON BOTH SIDES. NO INJURIES TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINUET 2 COMMUNITY BED FNL ARJOHUNTLEIGH 161AA4A1A

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other