inforMED
MalfunctionCCM

BODY PLETHSMOGRAPH

Received Mar 18, 2026 · Event occurred Feb 18, 2026

Report 2183022-2026-00001 · MDR key 24630510

Device

Generic name

Platinum Elite Dx

Model number

830008-902

Product problems

  • Failure to Deflate

Patient

63 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A REPORT WAS RECEIVED INDICATING THAT A PATIENT UNDERGOING PULMONARY FUNCTION TESTING BECAME TEMPORARILY TRAPPED INSIDE THE BODY PLETHYSMOGRAPH CHAMBER OF A PLATINUM ELITE DX SYSTEM. DURING TESTING, THE DOOR SEAL REMAINED INFLATED AND DID NOT DEFLATE AS INTENDED WHEN THE DOOR RELEASE MECHANISMS WERE ACTIVATED. ATTEMPTS BY CLINICAL STAFF TO OPEN THE CHAMBER DOOR WERE UNSUCCESSFUL BECAUSE THE INFLATABLE DOOR SEAL REMAINED FULLY PRESSURIZED. A BIOMEDICAL TECHNICIAN ATTEMPTED SEVERAL MITIGATION ACTIONS, INCLUDING REMOVING ELECTRICAL POWER FROM THE SYSTEM, REMOVING THE LOWER TRIGGER SWITCH, ACTIVATING THE EMERGENCY PANIC BUTTON, PRESSING THE DEFLATE CONTROL, AND DEPRESSURIZING THE GAS SUPPLY. DESPITE THESE ACTIONS, THE DOOR SEAL REMAINED INFLATED. AS A RESULT, THE STAFF ULTIMATELY CUT THE DOOR SEAL IN ORDER TO ALLOW THE PATIENT TO EXIT THE CHAMBER. THE PATIENT WAS RELEASED AFTER APPROXIMATELY 20 MINUTES IN THE BODY BOX.

Remedial action

  • Repair