inforMED
OtherCBF

NI

Received Dec 3, 2001

Report MW4003189 · MDR key 375721

Device

Generic name

Hyperbaric Oxygen Chamber

Manufacturer

*

Model number

NI

Catalog number

NA

Lot number

NA

Product problems

  • Reaction

Patient

NO INFO

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

COMPLAINANT REPORTEDLY HAD FILED IN COURT A COMPLAINT AGAINST OPERATOR/PRODUCT AT 8-10 YEARS AGO. CURRENT COMPLAINT CONTINUES THAT THESE HYPERBARIC OXYGEN CHAMBERS ARE DANGEROUS AND CAN CAUSE INJURY. THEY BELIEVE THAT THE UNITS IN USE ARE THE SAME UNITS THAT WERE IN OPERATION WHEN THEY SUFFERED THE OXYGEN TOXICITY PROBLEM. LOST LAWSUIT. COMPLAINANT INDICATES THAT THEY GOT OXYGEN TOXICITY WHEN THEY WERE A TECHNICIAN OPERATING THE HYPERBARIC CHAMBERS, YET THEY WERE NOT IN THE UNIT DURING HYPERBARIC CONDITIONS.