MEDLINE PADS

Description of Event or Problem

WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED. IT WAS REPORTED THAT THE UNIT HAD REM ISSUES. DURING TROUBLESHOOTING, THE FACILITY MENTIONED THAT THEY WERE USING NON-(B)(6) PADS. THE BIOMED WAS ADVISED TO TRY USING (B)(6) PADS AND RUN THE REM FUNCTION TEST TO CONFIRM REM FUNCTIONALITY. THERE WAS NO PATIENT INJURY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).