RX-1 MINI RHYTHM EXPRESS REMOTE CARDIAC MONITORING SYSTEM

Description of Event or Problem

CALL FROM PATIENT DUE TO DEVICE NOT LIGHTING UP INDICATING A CHARGE, TRIED SOFT RESET AND DEVICE ISN'T VIBRATING OR LIGHTING UP. DEVICE IS UNRESPONSIVE AND PATIENT STATED THAT EARLY THIS MORNING THE HOUSING OF THE DEVICE STARTED TO GET VERY HOT AND NOW HE HAS A BLISTER UNDER WHERE THE HOUSING WAS SITTING ON HIS CHEST.

Additional Manufacturer Narrative

INITIAL INVESTIGATION INDICATED WATER INGRESS INTO THE DEVICE. SOURCE IS NOT CLEAR FOLLOWING A THOROUGH INVESTIGATION OF THE DEVICE RX323937 (77E66ACA53) IT APPEARS THAT A SMALL AMOUNT OF LIQUID WAS INSIDE THE CASE OF THE RX-1 MINI AND RESULTED IN SHORTING OF ONE OR MORE COMPONENTS AND A HEATING OF THE OUTER SURFACE OF THE HOUSING. DIAGNOSTIC FILES DOWNLOADED FROM THE DEVICE SHOW THAT CURRENT WAS SLIGHTLY ELEVATED FOR ABOUT 90 MINUTES. IT IS ESTIMATED THAT THE DEVICE HOUSING TEMPERATURE WAS LIKELY ELEVATED TO ABOUT 45 DEG C. A MEDICAL EXPERT CONCLUDED THAT THE IMPACT OF THIS WARM TEMPERATURE ON TISSUE FOR EXTENDED PERIOD OF TIME WOULD RESULT IN A BLISTER IS CONSISTENT WITH EXPOSURE OF THE SKIN TO ~45 DEG C FOR 1.5 TO 2 HOURS. THE PATIENT SOUGHT MEDICAL TREATMENT FOR THE BLISTER THAT INCLUDED ANTIBIOTIC CREAM AND BROAD-SPECTRUM ANTIBIOTIC TREATMENT. NO KNOWN SIDE EFFECTS AND THE PATIENT HAS NO MEDICALLY SIGNIFICANT RESIDUAL EFFECTS.

Description of Event or Problem

IBC FROM PATIENT DUE TO DEVICE NOT LIGHTING UP INDICATING A CHARGE, TRIED SOFT RESET AND DEVICE ISN'T VIBRATING OR LIGHTING UP. DEVICE IS UNRESPONSIVE AND PATIENT STATED THAT EARLY THIS MORNING THE HOUSING OF THE DEVICE STARTED TO GET VERY HOT AND NOW HE HAS A BLISTER UNDER WHERE THE HOUSING WAS SITTING ON HIS CHEST.

Additional Manufacturer Narrative

INITIAL INVESTIGATION INDICATES WATER INGRESS INTO THE DEVICE. SOURCE IS NOT CLEAR.