BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATEC

    MDR report key: 775695 · Received October 30, 2006

    Report

    Report Number
    2134311-2006-00001
    Event Type
    Injury
    Date Received
    October 30, 2006
    Report Date
    October 25, 2006
    Manufacturer
    R.F. TECHNOLOGIES, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    10-24-06: ALARM PAD AND CONTROL UNIT WERE RETURNED ON RMA 406101. CONDUCTED A REVIEW OF THE EQUIPMENT. DATE OF USE ON PAD WAS 8-06 AND TAPE ON THE BACK OF PAD HAD NOT BEEN USED TO AFFIX UNIT TO THE BED. ALTHOUGH THE FACILITY WAS GIVEN BOTH VERBAL AND WRITTEN INSTRUCTIONS STATING THAT THEY WERE NOT TO FOLD THE PAD WHEN THEY RETURNED IT TO US, THE PAD ARRIVED FOLDED IN HALF. IT IS UNKNOWN WHETHER FOLD WAS CAUSED BY PACKAGING OR BY PATIENT USE. WHEN PAD WAS TESTED WITH THE RETURNED CONTROLLER, AND A KNOWN GOOD CONTROLLER, IT ALARMED EVERY TIME EXCEPT WHEN PLACED IN A 'V' TYPE OF POSITION USING THE FOLD ALREADY PRESENT. UPON OPENING THE ALARM PAD, IT WAS NOTED THAT ONLY ONE HALF OF THE INSIDE COMPONENTS SHOWED WEAR WHILE THE OTHER HALF WAS IN AN UNUSED CONDITION. THE MATERIALS IN THE WORN HALF ALSO APPEARED TO HAVE SHIFTED, OR BEEN 'CRUNCHED', TO ONE SIDE AWAY FROM THEIR ORIGINAL POSITION. UNFORTUNATELY, DUE TO THE FOLDED CONDITION OF THE PAD WHEN IT WAS RETURNED TO US, WE ARE UNABLE TO MAKE A DEFINITIVE DETERMINATION AS TO WHY THE UNIT DID NOT ALARM WHEN THE PATIENT GOT OUT OF BED.

    Description of Event or Problem · 1

    10-3-06: A CONFERENCE CALL WAS HELD.OUR GULF SOUTH REP WAS VISITING HIS LISTED CUSTOMER SITE LAST THURSDAY, 9-28-06, AND AT THAT TIME FOUND OUT ABOUT THE INCIDENT. THE PATIENT IS A FEMALE WHO WAS NOT VIEWED TO BE INCONTINENT AS SHE COULD ALERT STAFF TO HELP HER TO THE BATHROOM; THEREFORE SHE WAS NOT WEARING A BRIEF/ADULT DIAPER. HER LAST FALL WAS IN JANUARY 2006 - PATIENT HAS HISTORY OF FALLS. THE PATIENT PREFERS SLEEPING WITH BOTH THE HEAD AND FOOT OF HER BED RAISED AS FAR AS POSSIBLE. A 180-DAY PAD, IN USE SINCE JUNE 2006, WAS PLACED HORIZONTALLY ACROSS THE BED UNDER HER HIPS WITH AN INCONTINENCY PAD (PER FACILITY, PAD WEIGHS APPROXIMATELY 2 LBS) ON TOP OF IT. PATIENT AWOKE DURING THE NIGHT AND GOT OUT OF BED TO GO TO THE BATHROOM. AS SHE WAS WALKING, SHE URINATED AND THEN SLIPPED, FELL AND FRACTURED HER RIGHT HIP. THE ALARM DID NOT SOUND. PATIENT WAS TAKEN TO THE HOSPITAL AND HAD SURGERY THERE FOR HER INJURY. SHE WAS TO RETURN TO THE FACILITY IN 2006 FOR PHYSICAL AND OCCUPATIONAL THERAPY. CONFRENCE ATTENDEES' OPINION: THERE WERE TWO POSSIBLE REASONS FOR THE PAD NOT ALARMING. ONE WAS THAT THE PAD WAS PINCHED DUE TO THE HEAD AND FOOT OF THE BED BEING RAISED - PAD WAS PLACED UNDER PATIENTS' BUTTOCKS. THEIR OTHER CONJECTURE WAS THAT IT DIDN'T ALARM BECAUSE OF THE INCONTINENCY PAD BEING PLACED ON TOP OF THE SENSATEC PAD. THERE WAS ALSO A QUESTION IN THEIR MINDS AS TO WHETHER THE 180-PAD BEING THICKER THAN THE 90-DAY PAD COULD HAVE MADE A DIFFERENCE, AS THEY COULDN'T REPRODUCE THE EVENT USING A 90-DAY PAD. OUR GULF SOUTH REPTRIED TO REPRODUCE THE EVENT BY LYING ON THE PAD AND GETTING UP AS THE PATIENT DID. HE TRIED THIS TWICE WITH THE BED FLAT AND THE UNIT WORKED PERFECTLY, BUT WHEN HE TRIED IT WITH THE BED IN A 'V' SHAPE, AS THE PATIENT HAD HAD IT, THE UNIT FAILED BOTH TIMES. THE FAMILY IS NOT UPSET ABOUT THE INCIDENT AT THIS TIME. CUSTOMER CARE WILL CREATE AN INCIDENT TO DOCUMENT EVENT AND WILL SEND RMA AND REPLACEMENT UNIT. THEY HAVE THE PAD AND CONTROL UNIT SET ASIDE AND WILL SEND THEM BACK TO US FOR EVALUATION. IT IS BELIEVED, IT WAS PROBABLY A COMBINATION OF THE BED POSITION PINCHING THE PAD AND THE INCONTINENCY PAD BEING PLACED ON TOP OF IT. IT IS RECOMMENDED MOVING THE PAD UNDER A PATIENT'S SHOULDER BLADES WHEN THEY HAVE THE FOOT OF THE BED RAISED IN THIS MANNER. HE MENTIONED THAT THEY MIGHT WANT TO USE THE DELAY FEATURE AVAILABLE ON THEIR ST320 UNIT TO PREVENT MORE FREQUENT ALARMS AS A PATIENT CHANGES POSITION. IT IS NOT RECOMMENDED AN INCONTINENCE PAD ON TOP OF OURS WHEN THE BED IS RAISED TO A 'V' POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATEC BED MONITOR KMI R.F. TECHNOLOGIES, INC. ST260 *

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization