inforMED
MalfunctionCAN

FLOTEC FLOPAC REGULATOR

Received Sep 15, 2004 · Event occurred Aug 11, 2004

Report 1832475-2004-00003 · MDR key 5322447

Device

Generic name

Presure Regulator Integrated With Cylinders Valves

Manufacturer

Flotec, Inc.

Model number

FP4-XX-BO5-7005T2

Catalog number

FP4-XX-BO5-7005T2

Lot number

NA

Product problems

  • False Reading From Device Non-Compliance

Patient

NI

  • Low Oxygen Saturation

Narrative

Additional Manufacturer Narrative

CONCLUSION: GAUGE SHOWED INACCURATE PRESSURE BECAUSE DECAL RING CAUGHT ON GAUGE BODY AS THE PRESSURE FELL. CAUSE: DECAL RING WAS ASSEMBLED WITHOUT REQUIRED DEBURR PROCESS BEING PERFORMED AND GAUGE TUBE WAS ASSEMBLED WITHOUT THE REQUIRED PRESET PROCESS BEING PERFORMED BY ASSEMBLY PERSONNEL AT FLOTEC. CORRECTIVE ACTION TAKEN: CAR-04-084, CREATE WORK INSTRUCTION FOR INGAGE SUB ASSEMBLY AND FUNCTION TEST PROCEDURE, AND TRAIN ASSEMBLY PERSONNEL ON NEW WORK INSTRUCTIONS (WI-PRO-052). CAR-04-086, RETAIN TEST STATION OPERATORS TO ENSURE TEST WORK INSTRUCTIONS WI-QAL-00 AND WI-QAL-002 ARE BEING FOLLOWED PROPERLY. CAR-04-085, REVISE TEST FIXTURE TO HOLD FLOTEC REGULATOR IN "IN USE POSITION" WHICH WILL ENHANCE THE FINAL TESTING PROCESS OF THE INGAGE PRESSURE GAUGE.

Description of Event or Problem

VERBALLY REPORTED TO FLOTEC AS: PT UNDERGOING STRESS TEST EXPERIENCED LOW SPO2 LEVELS WHEN OXYGEN CYLINDER RAN OUT OF OXYGEN. CONTACTS GAUGE ON REGULATOR SHOWED INACCURATE PRESSURE RESULTING IN CYLINDER TANK RUNNING OUT OF OXYGEN BEFORE COMPLETION OF TEST. THE TEST HAD TO BE POSTPONED.

Remedial action

  • Repair
  • Other
  • Inspection