Description of Event or Problem · 0
AFTER SOME INVESTIGATION, IT HAS COME TO MY ATTENTION BY ONE OF MY TRAVEL NURSES THAT ACCUVEIN AV500 CAN OVERHEAT AND DAMAGE THE DEVICE IF IT STAYS CHARGING IT: THE ACCUVEIN IV POLES CHARGER. (HF580) WE WERE NEVER TOLD THAT KEEPING IT ON THE ACCUVEIN IV POLE CHARGER COULD CAUSE THIS ISSUE. IT JUST SO HAPPEN THAT ON THURSDAY (B)(6) 2026, I RECEIVED THE ACCUVEIN HF580 AND PUT IT TOGETHER. BIOMED CHECKED IT IN. THE VEINFINDER STAYED ON THIS CHARGER PLUGGED IN. IT WAS WORKING ON THURSDAY AND FRIDAY. AFTER BEING PLUGGED IN ALL WEEKEND, WE CAME IN ON MONDAY MORNING THE DEVICE WAS HOT TO THE TOUCH AND THE ERROR 04 WAS SEEN ON THE SCREEN. ERROR 04 WAS AN ERROR THAT REQUIRES THE DEVICE TO BE REPLACED AS THE LASER IS NO LONGER FUNCTIONAL. IT SOUNDS THAT THE CHARGER ON THE ACCUVEIN POLE CAUSED THE VEINFINDER TO OVERHEAT. THIS WAS NOT CONVEYED TO US WHEN WE PURCHASED THIS ACCUVEIN POLE FROM YOU. SINCE THIS IS A KNOWN ISSUE, I BELIEVE ACCUVEIN SHOULD REPLACE OUR DEVICE AT NO CHARGE AND REPORT THIS TO THE FDA. THESE DEVICES INVOLVED ARE IN THE PROCESS OF BEING SENT TO THE MANUFACTURER TO BE TESTED. (DUE TO THE NATURE OF THE COMPLAINT (OVERHEATING), THIS EVENT MUST BE REPORTED TO THE FDA UNDER 21 CFR 803. OUR ENGINEERING TEAM WILL ALSO NEED TO CONDUCT A THOROUGH INVESTIGATION ON THIS AV500 DEVICE AND YOUR HF580 STAND IT WAS BEING USED WITH). HEALTH EFFECT CODE: 4582. DEVICE PROBLEM CODE: 1437. REFERENCE REPORT: MW5186798.