MGC Diagnostics 830008-902Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810016250241), received between Mar 17, 2023 and Mar 18, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Explosion” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Failure to Deflate

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630510 ↗
• InjuryMar 17, 2023Misassembly by Users; Explosion; Misassembly by Users; Explosion

  CHIEF OF RESPIRATORY CARE REPORTED TO THE MANUFACTURER'S REPRESENTATIVE THAT AN EMPLOYEE HAD DISCONNECTED THE COMPRESSED GAS REGULATORS WHILE MOVING THE GAS CYLINDERS WITHIN THE TESTING LABORATORY. WHEN THE EMPLOYEE RECONNECTED THE REGULATORS AND TURNED ON THE 100% OXYGEN, THE REGULATOR EXPLODED AND A 2-3 FOOT LONG FLAME EMERGED FROM THE REGULATOR BODY. THE EMPLOYEE RECEIVED FIRST AND SECOND DEGREE BURNS TO THE FACE, TORSO, ARM, AND HAND AND WAS TAKEN TO THE HOSPITAL FOR TREATMENT. THE FIRE WAS EXTINGUISHED BY ANOTHER EMPLOYEE. NO PATIENTS WERE PRESENT OR INJURED DURING THE INCIDENT.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 16566090 ↗