BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA DEVICE NOT SUSPECT MODEL SELECTAIR STANDARD

    MDR report key: 766069 · Received September 27, 2006

    Report

    Report Number
    1419507-2006-00001
    Event Type
    Death
    Date Received
    September 27, 2006
    Date of Event
    August 17, 2006
    Report Date
    September 26, 2006
    Manufacturer
    ROHO, INC.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL NOTIFICATION BY THE FACILITY WAS VIA PHONE MESSAGE, REQUESTING TELECONFERENCE PARTICIPATION. SPOKE WTH UF WHO GAVE A LITTLE MORE INFORMATION ABOUT THE EVENT. NO ALLEGATION OF PRODUCT DEFECT OR MALFUNCTION WAS INDICATED. THE FACILITY INFORMED US THAT THEY RECEIVED THE MATTRESS FROM SUPPLIER AND ALLEGED THAT SUPPLIER DID NOT PROVIDE THE MATTRESS COVER OR OPERATIONS MANUAL THAT ARE STANDARD COMPONENTS. THEY ALSO STATED THAT SUPPLIER EVALUATED THE MATTRESS AND FOUND NO DEFECTS IN ITS PERFORMANCE. THE RESIDENT'S CHART REPORTEDLY DID NOT INDICATE MATTRESS SETTINGS AT THE TIME OF THE EVENT. THE STAFF WE SPOKE WITH WERE UNCERTAIN AS TO WHO SET UP THE MATTRESS INITIALLY, OR IF ANY STAFF USE TRAINING WAS CONDUCTED.

    Description of Event or Problem · 1

    NOTIFIED BY USER FACILITY THAT AN IMMOBILE, ELDERLY FEMALE RESIDENT AT THEIR FACILITY WAS FOUND WITH HER NECK RESTING AGAINST THE RIGHT SIDE BEDRAIL. CORONER DETERMINED CAUSE OF DEATH TO BE "POSITIONAL ASPHYXIA". THE RESIDENT WAS ON A ROHO SELECTAIR STANDARD MATTRESS REPLACEMENT AND A CARROLL/INVACARE SOLO BED. THE BED WAS REPORTEDLY AT A 30DEGREE ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA DEVICE NOT SUSPECT MODEL SELECTAIR STANDARD LOW AIR LOSS MATTRESS REPLACEMENT FNM ROHO, INC. SASTDSYS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death PATIENT ALSO ON A CARROLL/INVACARE SOLO BED.