BED, FLOTATION THERAPY, POWERED

Description of Event or Problem

(B)(6) WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH (B)(6) IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A MANUFACTURER HILL-ROM BED, SERIAL NUMBER UNKNOWN THAT HAD REDUCED BRAKE FORCE, A BASE WITH AN ABNORMAL NOISE, AND AN INOPERABLE SIDE RAIL. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).