FLOTEC
Received Nov 13, 2001 · Event occurred Oct 27, 2001
Report MW1023382 · MDR key 360428
Device
Product problems
- Detachment Of Device Component
- Fire
- Magnetic interference
- Replace
- Sparking
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE FLOTEC OXYGEN REGULATORS COME WITH A YOKE WASHER SEAL WHICH, AFTER A COUPLE OF USES, TENDS TO COME OFF THE REGULATOR. A RESPIRATORY THERAPIST WAS UNABLE TO LOCATE A FLOTEC SEAL, AND USED THE PLASTIC SEAL PROVIDED WITH THE O2 TANK PLUS ANOTHER PIECE OF FLEXIBLE MATERIAL HE OBTAINED FROM A HEAD DEVICE. HE THEN TURNED ON THE OXYGEN TANK, JIGGLED THE REGULATOR CAUSING A SPARK WHICH IGNITED THE SEAL MATERIALS AND RESULTED IN A FIRE. THERE WAS NO PT INVOLVED AND THE RESPIRATORY THERAPIST WAS NOT INJURED. THE TWO PROBLEMS ARE 1- THAT THE YOKE WASHER SEALS REQUIRE FREQUENT REPLACEMENT SINCE THEY DO NOT STAY ON THE REGULATORS, AND 2- THE MFR HAS INDICATED THAT ONLY FLOTEC YOKE WASHER SEALS SHOULD BE USED ON ITS REGULATORS, BUT THAT IS NOT CLEARLY INDICATED IN THE PRODUCT INSERT.