BEUDAMED
    FDA Adverse Event Summary report: N

    ATMOSAIR 90000 AR

    MDR report key: 824192 · Received March 5, 2007

    Report

    Report Number
    1320918-2007-00001
    Date Received
    March 5, 2007
    Date of Event
    December 28, 2006
    Report Date
    February 23, 2007
    Manufacturer
    WCW, INC.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INITIAL REPORT VIA THE DISTRIBUTOR, IT IS UNCLEAR AS TO THE TIME (SHIFT) IN WHICH THE BED WAS ACTUAL SET UP. THE INITIAL REPORT STATES THAT THE REPORT WAS CALLED IN ON THE 28TH, HOWEVER, THE CONTACT PERSON STATED THE MATTRESS WAS SET UP ON THE 29TH. IT WAS ALSO STATED THAT FACILITY STAFF DID NOT WITNESS THE FALL, BUT WERE SUMMONED TO THE ROOM BY THE ROOMATE'S CALL LIGHT. IN ADDITION, THE INSTRUCTIONS FOR USE STATE, "ENSURE THAT ALL SIDE RAILS ARE LOCKED IN FULL UPRIGHT POSITION BEFORE ROTATING. IT IS RECOMMENDED THAT SIDE RAILS BE LOCKED ON IN FULL UPRIGHT POSITION WHEN UNATTENDED. CONSULT A PHYSICIAN AND CAREFULLY CONSIDER THE USE OF PATIENTS PROTECTIVE RESTRAINTS, BOLSTERS, POSITIONING AIDES, FLOOR PADS, LOW BED, OR PADDED SIDE RAIL ACCESSORIES WHEN APPROPRIATE, ESPECIALLY WITH CONFUSED, RESTLESS OR AGITATED PATIENTS." (PRODUCT LABELING SAMPLING ATTACHED) THE CONTACT PERSON AT HCR SPOKE WITH A MEDICAL REP FOR KCI AND STATED THAT THE DEVICE DID NOT CAUSE THE INJURY. SHE STATED THAT THE KCI DRIVERS USUALLY TAPE OFF THE ROTATIONAL PORT, BUT THAT WAS NOT DONE THIS TIME DUE TO THE DELIVERY TIME. SHE ALSO REPORTED THAT THEY NEVER USE ROTATIONAL SURFACES AT THEIR FACILITY BECAUSE THEY ARE NOT ALLOWED TO USE SIDE RAILS. SHE ADDED THAT THE MATTRESS HAD BOLSTERS. IN SUMMARY, AND BASED UPON THE STATEMENTS IN THE COMPLAINT, THE "INSTRUCTIONS FOR USE" AND PRECAUTIONARIES WERE NOT ADHERED TO WITH REGARDS TO USAGE IN A ROTATIONAL THE FILING OF THIS REPORT AND DETERMINE IF THERE SHOULD BE FURTHER REVIEW OF THIS INCIDENT.

    Description of Event or Problem · 1

    PATIENT FELL OUT OF THE BED AFTER BEING PLACED ON HIS SIDE WITH PILLOWS, AND NO SIDE RAILS ENGAGED, WHEN MATTRESS WAS PLACED ON ROTATIONAL MODE. THE CALLER STATED THAT, THE ROTATIONAL MODE ACCESS WAS TO BE TAPED OFF BY KCI DELIVERY REP, SO NOT TO BE USED. THIS WAS NOT DONE AS THE MATTRESS WAS DELIVERED AFTER HOURS. THE APPARENT CONTRACTUAL AGREEMENT BETWEEN KCI AND HCR WAS TO NOT SET UP MATTRESS IF DELIVERED AFTER HOURS. DAY SHIFT WOULD DO IT THEMSELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATMOSAIR 90000 AR ALTERNATING PRESSURE AIR FLOTATION MATT FNM WCW, INC. ATMOSAIR 9000AR *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention