Drive OM-900ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383018515), received between Mar 1, 2023 and Mar 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Flare or Flash” (2 reports).

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 16, 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 1, 2023Flare or Flash; Flare or Flash

  INOVO INC. WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONSERVER BY A PROVIDER WHO STATED THAT "A PATIENT HAD FITTED THE CONSERVER ONTO A CH MEDICAL OXYGEN CYLINDER BUT DID NOT TURN IT ON. APPROXIMATELY 24 HOURS LATER, THE PATIENT NEEDED TO VISIT THE GP AND WHEN OUTSIDE THE GP'S CLINIC THEY TURNED IT ON. AT THAT POINT THE PATIENT HEARD A HISSING NOISE AND THEN A BANG." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. INOVO EVALUATED THE PRODUCT, WHICH REVEALED THAT THE IGNITION MECHANISM WAS FLOW FRICTION, WHICH CAN OCCUR IF THE SEAL WASHER WEARS OVER TIME, OR IF THE DEVICE IS NOT CONNECTED TO THE COMPRESSED OXYGEN CYLINDER TIGHTLY ENOUGH, BOTH OF WHICH ARE ADDRESSED BY THE DEVICE'S INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460357 ↗
• MalfunctionMar 1, 2023Flare or Flash; Flare or Flash

  INOVO INC. WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONSERVER BY A PROVIDER WHO STATED THAT "AN END USER ATTACHED A FULL CYLINDER TO THE OXYGEN CONSERVER AND WHEN HE OPENED THE CYLINDER A LARGE FLASH WAS SEEN." THE END USER IMMEDIATELY CLOSED THE CYLINDER VALVE. IT WAS REPORTED THAT A LARGE AMOUNT OF SOOT WAS SEEN AROUND THE CYLINDER VALVE AND OXYGEN CONSERVER. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. INOVO EVALUATED THE PRODUCT, WHICH SUGGESTED THAT THE IGNITION MECHANISM WAS FLOW FRICTION, WHICH CAN OCCUR IF THE SEAL WASHER WEARS OVER TIME, OR IF THE DEVICE IS NOT CONNECTED TO THE COMPRESSED OXYGEN CYLINDER TIGHTLY ENOUGH, BOTH OF WHICH ARE SPECIFICALLY ADDRESSED BY THE DEVICE'S INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460346 ↗