BLANKETROL III HYPER-HYPOTHERMIA MACHINE
Received May 16, 2025 · Event occurred May 7, 2025
Report MW5170532 · MDR key 22039466
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
27 YR · Male
- Alteration in Body Temperature
- Alteration in Body Temperature
Narrative
Description of Event or Problem
PATIENT WAS ON COOLING BLANKET AND BECAME FEBRILE. SHORTLY AFTER, THE MACHINE WAS READING "CHECK PROBE." AFTER TROUBLESHOOTING, NO SUCCESS. MACHINE WAS SWAPPED OUT AND THE NEW ONE WAS READING THE SAME THING. ESOPHAGEAL PROBE WAS THEN SWAPPED OUT, AND COOLING BLANKET BEGAN WORKING AGAIN, HOWEVER THE TEMPS WERE REPORTING BACK VERY LOW. X-RAY VERIFICATION OF PROBE WAS COMPLETED, AND SUCCESSFUL, AND ORAL TEMP WAS TAKEN TO CONFIRM PATIENT WAS ACTUALLY HYPOTHERMIC. OLD MACHINE WAS RED TAGGED. UNSURE IF THE FIRST MACHINE, OR PROBE WAS INACCURATELY REPORTING HIGH TEMPS, VS REMAINED STABLE AT ALL TIMES. MDS AND CHARGE NURSES NOTIFIED.