inforMED
MalfunctionCAN

FLOTEC

Received Nov 13, 2001 · Event occurred Oct 27, 2001

Report MW1023382 · MDR key 360428

Device

Generic name

Yoke Washer Seal

Manufacturer

Flotec, Inc.

Model number

*

Catalog number

*

Lot number

*

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.