BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROHO SELECTAIR LOW AIR LOSS MATTRESS SYSTEM

    MDR report key: 1550640 · Received October 28, 2009

    Report

    Report Number
    1419507-2009-00001
    Event Type
    Death
    Date Received
    October 28, 2009
    Date of Event
    June 21, 2009
    Report Date
    October 23, 2009
    Manufacturer
    ROHO, INC.
    Product Code
    FNM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY HAD ISSUED A VOLUNTARY REPORT. VERY LITTLE INFO WAS NOTED ON THE MEDWATCH REPORT; COULD NOT IDENTIFY FACILITY, LOCATION, OR EVEN PRODUCT, WHICH WAS MISLABELED IN THE REPORT AS PRODUCT AS A NONPOWERED FLOTATION THERAPY MATTRESS, WHEN IT SHOULD HAVE BEEN A POWERED FLOATATION THERAPY BED. DID NOT HEAR BACK. RECALLED ON OCTOBER 19. REACHED THE PERSON WHO HAD TO ASCERTAIN IF THE FACILITY WAS WILLING TO DIVULGE ADD'L INFO. SHE CALLED BACK WITH FACILITY'S CONTACT INFO. SPOKE WITH A MGR AT FACILITY OVER QUALITY & COMPLIANCE, WHO GAVE ME INFO USED IN THIS REPORT. OUR STAFF CONTACTED THE DME PROVIDER ON OCT. 23 AND OBTAINED ADD'L INFO ABOUT THE PRODUCT & THE INCIDENT, ALSO USED IN THIS REPORT. THE STAFF AT THE DME, REPORTEDLY CHECKED THE SELECTAIR MAX LAL MATTRESS SYSTEM AND DETERMINED THAT IT WAS FUNCTIONING PROPERLY, CONFIRMING WHAT THE FACILITY'S MANAGER HAD STATED. THE DME PROVIDER PLACES A STICKER OVER COMFORT LEVELS SET FOR THE PT. WHEN THEY REC'D THE MATTRESS BACK, THE STICKER WAS STILL IN PLACE, INDICATING THAT THE STAFF DID NOT ALTER THE SETTING. THE DME PROVIDER WAS REPORTEDLY TOLD BY THE FACILITY, THAT THE ISSUE WAS CONSIDERED AN ACCIDENT & HAS BEEN CLOSED.

    Description of Event or Problem · 1

    TWO FACILITIES WERE PERFORMING PT CHECKS & FOUND THAT A RESIDENT HAD SLID OFF THE SELECTAIR MAX LOW AIR LOSS (LAL) MATTRESS REPLACEMENT SYSTEM, WITH HIS HEAD BETWEEN THE MATTRESS & THE SIDE RAIL. PT WAS STILL BREATHING. THE STAFF REMOVED THE PT, PLACED HIM ON THE FLOOR, AND A WITHIN A SHORT TIME, POSSIBLY MINUTES OR SECONDS, HE PASSED AWAY. THE BED WAS DESCRIBED BY FACILITY'S MANAGER AS A STANDARD HOSPITAL BED AND THE SIDE RAIL AS A STANDARD HALF RAIL. THE SELECTAIR MAX LAL MATTRESS REPLACEMENT SYSTEM WAS A RENTAL UNIT FROM A DME PROVIDER. ACCORDING TO THE MANAGER, SHE BELIEVED THAT THE DME PROVIDER'S STAFF HAD SET-UP THE SELECTAIR MAX MATTRESS, AND DID KNOW THAT COMPANY TRAINED STAFF ON PROPER USE OF THE MATTRESS. THE MATTRESS WAS BROUGHT IN APPROX 2 TO 3 WEEKS PRIOR TO THE ADVERSE EVENT & ACCORDING TO FACILITY'S MANGER, WAS WORKING PROPERLY AT THE TIME OF THE ADVERSE EVENT. NURSING FACILITY RETURNED THE MATTRESS TO THE DME PROVIDER, & THEY CURRENTLY HAVE THE MATTRESS IN THEIR FACILITY. THE DIRECTOR OF SALES HAS STATED THAT THEY CHECKED THE MATTRESS AND & WAS & IS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROHO SELECTAIR LOW AIR LOSS MATTRESS SYSTEM ROHO SELECTAIR LOW AIR LOSS MATTRESS SYS FNM ROHO, INC. SELECTAIR MAX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death STANDARD HOSPITAL BED| MANAGER DID NOT KNOW MAKE OR MODEL.| STANDARD HALF RIAL SIDE RAIL