HOLTER MONITOR CLARUS 30

Additional Manufacturer Narrative

ATTEMPTED TO CONTACT REPORT SUBMITTER MULTIPLE TIMES VIA EMAIL. NO RESPONSE FROM REPORT SUBMITTER. THE DEVICE IN QUESTIONS WAS NEVER PROVIDED TO TZ MEDICAL FOR REVIEW. THE DESCRIPTION OF THE EVENTS DOES NOT SUPPORT A DEVICE MALFUNCTION. 1. DEVICE DOES NOT APPLY PRESSURE TO PATIENT. BRUISES WOULD HAVE BEEN CAUSED BY LAYING ON DEVICE. THIS IS A FUNCTION OF PATIENT ACTIVITY AND MOVEMENT. MOST PATIENTS WILL REPOSITION THEMSELVES IF DEVICE IS UNCOMFORTABLE. 2. 1ST DEGREE BURNS. DEVICE HAS INTERNAL TEMPERATURE THERMISTOR WHICH PREVENT IT FROM OVERHEATING BY SHUTTING DOWN PRIOR TO REACHING 150 DEGREES F. FOR DEVICE TO MELT WOULD REQUIRE INTERNAL BATTERY PROBLEM. THE SEQUENCE OF EVENTS WOULD BE THE SAME AS A BATTERY IN A CELL PHONE OR LAPTOP COMPUTER FAILING. BATTERY WOULD OVER HEAT, EXPAND, AND POTENTIALLY MELT CASING. THIS WOULD RENDER THE DEVICE UNUSABLE. WE WOULD EXPECT A DEVICE THAT FAILED IN THIS MANNER TO BE RETURNED BY PROVIDER. SINCE THE DEVICE HAS NOT BEEN RETURNED AND IS STILL IN THE FIELD, WE HAVE TO ASSUME IT IS STILL FULLY FUNCTIONAL. SINCE DEVICE HAS NOT BEEN RETURNED (WE HAVE NOT RECEIVED A DEVICE THAT HAS MELTED AS DESCRIBED IN THE REPORT), THE MOST COMMON SEQUENCE OF EVENTS IS THAT THE PATIENT HAD AN ADVERSE REACTION TO THE ADHESIVE USED TO ADHERE THE PATCH TO THE SKIN. INSTRUCTIONS CLEARLY STATE THAT PHYSICIAN SHOULD ASSESS SKIN SENSITIVITY OF PATIENT BEFORE APPLYING PATCH. OPTIONS TO USE SENSITIVE SKIN ELECTRODES ARE AVAILABLE FOR PATIENTS THAT WOULD EXHIBIT POTENTIAL SKIN REACTION. A LOW-GRADE SKIN REACTION TO THE ADHESIVE WOULD RESULT IN A RED AREA ON THE SKIN IN THE SHAPE OF THE PATCH THAT WOULD HAVE A REDNESS SIMILAR TO A SUPERFICIAL 1ST DEGREE BURN.

Description of Event or Problem

RECEIVED REPORT FROM FDA MW5117741. SUBMITTER WOULD NOT RESPOSND TO EMAIL FROM TZ MEDICAL.