inforMED
MalfunctionNFB

EASY PULSE CONSERVER

Received Sep 30, 2002 · Event occurred Sep 25, 2002

Report 2523148-2002-00004 · MDR key 419228

Device

Generic name

Oxygen Conserver

Model number

188705

Catalog number

*

Lot number

*

Product problems

  • Increase in Pressure
  • Other (for use when an appropriate device code cannot be identified)

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

EASY PULSE CONSERVER WAS BEING PLACED ON AN OXYGEN TANK AFTER THE YOKE SEAL WAS CHANGED. WHEN THE POST VALVE WAS OPENED ON THE TANK THE CONSERVER FLEW APART, HITTING THE HAND OF THE ATTENDING HOME CARE TECH; PART OF THE CONSERVER PUNCTURED A NEARBY WALL. THE PT RECEIVING THE OXYGEN WAS NOT INJURED.

Remedial action

  • Inspection