FORT HAS RECEIVED A REPORT OF ADVERSE EVENT FROM DRIVE MEDICAL, ONE OF OUR DISTRIBUTORS IN THE US. IT WAS ALLEGED THAT A HOSPICE PATIENT WAS GIVEN MEDICATIONS AT 7:30 AM OF THE DATE OF EVENT WHILE HE WAS IN THE BED, AND ALLEGEDLY AT 11 PM HE WAS FOUND DECEASED IN A POSITION OF KNEELING NEXT TO THE BED, WITH HIS HEAD BETWEEN THE BED RAIL AND MATTRESS. ACCORDING TO INFORMATION HIS DAUGHTER RECEIVED FROM THE CORONER, THAT THE CAUSE OF DEATH WAS ALLEGEDLY SUFFOCATION. AMONG OTHER CONCOMITANT MEDICAL DEVICES, THE ALLEGED BED RAIL WAS ORIGINALLY MANUFACTURED BY FORT AND IMPORTED TO THE US BY (B)(4). THIS MDR REPORT IS BASED ON THE INFORMATION PROVIDED BY THE ASSISTED LIVING FACILITY, THE HOSPICE COMPANY AND (B)(4).
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Patient 1
SINCE THERE IS NO REPORT OF DEFECT IN THE ALLEGED RAIL, AND THE ALLEGED RAIL WAS NOT RETURNED TO FORT, WE ARE UNABLE TO EVALUATE IT AND DETERMINE THE ROOT CAUSE OF THE ADVERSE EVENT. HOWEVER, WE HAVE RE-CONDUCTED AN ASSESSMENT ON ALL THE SEVEN (7) ZONES RECOMMENDED BY THE FDA ON THIS MODEL OF BED RAIL. THE ASSESSMENT WAS CONDUCTED ACCORDING TO THE FDA GUIDANCE TITLED "HOSPITAL BED SYSTEM DIMENSIONAL AND ASSESSMENT GUIDANCE TO REDUCE BED SYSTEM DIMENSIONAL AND ASSESSMENT GUIDANCE TO REDUCE ENTRAPMENT" ISSUED ON MARCH 10, 2006. FOT HAS CONCLUDED THAT EXCEPT ZONE 7, WHICH DOES NOT APPLY TO A BED RAIL, ALL OTHER SIX (6) ZONES WERE EVALUATED AND CONSIDERED TO BE IN COMPLIANCE WITH THE FDA GUIDANCE. MANUFACTURERS FOR CONCOMITANT MEDICAL PRODUCTS: (B)(4).