Description of Event or Problem · 0
FX8 REM NOT ALARMING, TURNING ON WHEN PAD ATTACHED, BIOMED CALLING IN ASKING FOR TROUBLESHOOTING, CHECKED SOFTWARE VERSION, CORRECT. CHECKED ZMAG OPEN CIRCUIT WHICH IS READING 2407-2420 WHICH IS BELOW 3K OHMS, IN SPECS, ADVISED TO FIND REM PAD AND ATTACH TO UNIT, AND CHECK TO SEE IF GREEN LIGHT WOULD TURN ON, REM PAD DOESN'T SEEM LIKE OUR PART NUMBER, PART NUMBER HE GAVE ME WAS 800A992 WHICH IS FROM MEDLINE, WHICH COULD BE A POSSIBLE ISSUE. ADVISED ON CHECKING REMAINDER OF THE OUTPUT FOR REM TO SEE IF WE CAN TRIGGER THE ALARM, ADVISED ALSO THAT 3RD PARTY REM PADS ARE NOT TESTED AND WILL CAUSE ISSUES, GAVE INFO TO SERVICE IN REPAIR INCASE SPECS DO NOT PASS AND HE NEEDS TO SEND IT IN FOR REPAIR, EMAILED SERVICE MANUEL AND SPEC SHEET FOR REM TESTING. NO PATIENT INVOLVEMENT, POC VERIFIED, DOCUMENTING FOR VISUAL, BIOMED WILL CONTINUE TO TEST. WILL CALL BACK IF HE NEEDS ADDITIONAL HELP. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".