BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALYPSO

    MDR report key: 3201906 · Received June 27, 2013

    Report

    Report Number
    1419652-2013-00151
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DETAILS INITIALLY REPORTED BY THE CUSTOMER: 'AS REPORTED BY TELEPHONE DISCUSSION DURING BATHING TREATMENT USING ARJOHUNTLEIGH BATH CHAIR (PRESUMABLY THE CALYPSO BUT REPORTER UNABLE TO ADVISE EXACT NAME) WITH BLUE AND WHITE BACKREST, RESIDENT ALMOST FELL/SLIPPED OFF THE CHAIR. RESIDENT DID NOT SLIP OFF THE CHAIR. FACILITY CLASSIFIED THIS AS A "NEAR MISS' IN THEIR INCIDENT CATEGORY, NO INJURIES WERE SUSTAINED BY THE RESIDENT OR CAREGIVER. UPON INVESTIGATION, REPORTER ADVISED THAT SHE BELIEVES THAT THE SAFETY BELT WAS NOT APPLIED PROPERLY AND THE RESIDENT WAS NOT SEATED CORRECTLY ON THE CHAIR. SINCE THE INCIDENT HAS TAKEN PLACE THE FACILITY HAS HAD FOLLOW UP IN SERVICING ON USE OF THE PRODUCT AND THE CAREGIVER WAS ADVISED OF SAFE AND PROPER USE OF THE CHAIR. CUSTOMER BOOKED REPEAT FOLLOW UP TRAINING ON CHAIR FOR (B)(6) 2013.' REF MFR NUMBER: 9611530-2013-00058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293120 CALYPSO NONE FSA ARJO HOSPITAL EQUIPMENT AB 219100-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Other