TRUSAT PULSE OXIMETER

Additional Manufacturer Narrative

PT INFO HAS BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. THE EXACT ACCIDENT DATE IS UNK, BUT IT IS BELIEVED THAT THE EVENT OCCURRED ON OR BEFORE (B)(6) 2011. NO ADDITIONAL INFO WAS RECEIVED ABOUT THE SENSOR TYPE OR THE ALLEGED INJURY. SEVERAL REQUESTS WERE MADE FOR ADDITIONAL INFO AND FOR RETURN OF THE UNIT FOR INVESTIGATION. NO ADDITIONAL INFO HAS BEEN RECEIVED NOR HAVE ANY UNITS BEEN RETURNED. THERE ARE THREE TYPES OF SENSORS THAT CAN BE USED WITH THE (B)(4). ALL OF THESE ARE WRAP SENSORS (REUSABLE AND DISPOSABLE MODELS) AND THE CUSTOMER COULD HAVE USED ANY OF THESE SENSORS. THERE HAVE BEEN NO COMPLAINTS INVOLVING ALLEGED BURNS IN WHICH THE MEASURED TEMP OF THE SENSOR EXCEEDED THE ALLOWED TEMPERATURE OF 41 DEGREES CELSIUS (B)(4). IN MOST CASES, IT WAS DETERMINED THAT THE CAUSE OF THE BURNS WAS DUE TO THE USER NOT ROTATING THE SENSOR AS FREQUENTLY AS INSTRUCTED IN THE OPERATOR'S MANUAL. SINCE NO SAMPLES WERE RETURNED FOR INVESTIGATION THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

Description of Event or Problem

A DISTRIBUTOR OF THE (B)(4) RECEIVED A REPORT FROM THE MOTHER OF A BABY STATING THAT THE DEVICE HAD BURNED HER BABY'S FOOT.