inforMED
InjuryCBF

HYPERBARIC CHAMBER

Received Aug 27, 2010 · Event occurred Jul 29, 2010

Report 2020676-2010-00025 · MDR key 1824586

Device

Generic name

Chamber, Hyperbaric

Model number

3200

Catalog number

3200

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Hearing Loss
  • Seizures
  • Seizures, Grand-Mal

Narrative

Additional Manufacturer Narrative

PT INFO OUTCOME AND ANY ADD'L INFO WILL BE PROVIDED UPON RECEIPT FROM USER FACILITY.

Description of Event or Problem

THREE PTS EXPERIENCED AUDITORY SEIZURES WITHIN THE LAST 2 WEEKS. ALL 3 PTS INVOLVED REPORTEDLY DO NOT HAVE ANY SEIZURE HISTORY. ONE REPORTED SEIZURE TURNED INTO GRAND MAL SEIZURE. THE CHAMBER WAS DEPRESSURIZED AND THE PT WAS SENT TO THE ER. IN THE OTHER TWO SEIZURES, THE CHAMBER WAS COMPRESSED TO AIR AND WITHIN 5 MINUTES THE PT'S HEARING CAME BACK AND THE SEIZURE STOPPED. BOTH TREATMENTS WERE STOPPED.