inforMED
MalfunctionCAN

FLOTEC

Received Jan 22, 1999 · Event occurred Jan 17, 1999

Report MW1015484 · MDR key 207262

Device

Generic name

Portable Oxygen Regulator

Manufacturer

Flotec, Inc.

Model number

NI

Catalog number

NI

Lot number

NI

Product problems

  • Dislodged
  • Repair
  • Replace
  • Other (for use when an appropriate device code cannot be identified)

Patient

UNKNOWN

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

CALLER WISHES TO REPORT A POTENTIAL HAZARD FOR THE USE OF A PORTABLE OXYGEN REGULATOR. RPTR STATES THAT THE THREADED INSERT THAT IS USED TO REGULATE PRESSURE IS MADE OF "CHEAP ALUMINUM". ON MANY OCCASION, IT HAS "SHOT OUT" OF THE REGULATOR. RPTR IS CONCERNED, BECAUSE THE PROJECTILE CAN CAUSE INJURY, AND PT WHO NEED OXYGEN ARE AT RISK FOR GOING WITHOUT DUE TO FAULTY REGULATORS. RPTR STATES THAT ON AVERAGE, 3 OF 5 REGULATORS FAIL. FOR THIS EVENT, THE INSERT POPPED OUT, BUT NO ONE WAS INJURED. THE PT WAS BEING TRANSPORTED INTO THE AMBULANCE DURING THE EVENT, SO "BOARD" OXYGEN WAS PLACED ON PT. RPTR STATES THAT HE HAS CONTACTED THE SERVICING AGENT, WHO REPAIRS THE DEVICES.