Description of Event or Problem · 1
COMPLAINANT IS A NURSE WORKING FOR A HOME HEALTH CO. SHE IS REPORTING A BED THAT MALFUNCTIONED AND CAUSED HER PT'S WOUNDS TO GET WORSE. PT'S MALFUNCTIONING BED WAS REPLACED ON 5/18/98. REC'D BY FDA ON 9/24/98. FIRM IS SCHEDULED FOR A RE-INSPECTION ON 2/1/98. A NURSE WORKING FOR A HOME NURSING AGENCY CALLED TO COMPLAIN ABOUT A MALFUNCTIONING BED THAT WAS RENTED FOR A HOME PT OF HERS. SHE DESCRIBED THE BED AS BEING A LOW AIR LOSS FLUIDIZED BED USED TO SUSPEND OR "FLOAT" THE PT THROUGH A COMBINATION OF BLOWING AIR, SAND, AND A THIN LAYER OF MESH. THE BED IS USED IN THE HEALING OF WOUNDS. THE COMPLAINANT STATED THAT THE BED WAS NOT INFLATING PROPERLY, CAUSING HER PARAPLEGIC PT TO SINK INTO THE BED. THE PT'S WOUNDS ACTUALLY GOT WORSE FROM THE HOT AIR DRYING IT OUT (THIS WAS DOCUMENTED). AFTER SEVERAL CALLS TO THE DISTRIBUTOR AND MFR, SVC PERSONNEL WERE SENT OUT ON TWO OCCASIONS TO FIX THE BED. THE MALFUNCTION WAS NEVER CORRECTED-THE PT KEPT SINKING INTO THE BED. THE COMPLAINANT CALLED THE MFR BACK UP TO REQUEST THAT THEY PICK UP THE BED BECAUSE SHE WAS GETTING ANOTHER ONE FROM A DIFFERENT MFR. SHE SAID A REP FOR KCI, INC, WAS RUDE AND HUNG UP ON HER DURING ONE CONVERSATION. AFTER FINALLY DECIDING TO PICK UP THE BED, KCI, INC SENT OUT PERSONNEL WITHOUT NOTICE ON 5/18/98-THE PT HAD TO SIT IN A WHEELCHAIR FOR SEVERAL HOURS, UNTIL HER NEW BED ARRIVED. THE COMPLAINANT WAS INFORMED THAT THE PT'S MEDICARE WOULD BE BILLED FOR THE 5 DAYS THAT THEY HAD THE BED (5/13/98 UNTIL 5/18/98). THE COMPLAINANT ADDED THAT A REP FROM THE DISTRIBUTOR CO, WAS VERY HELPFUL IN HELPING HER OUT. THE DISTRIBUTOR REP WROTE LETTERS TO KCI, INC TO INFORM THEM OF THE PROBLEM WITH THEIR BED.