Roscoe Medical O2C5LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00092237623152), received between Sep 19, 2024 and Nov 15, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 9, 2024Class IOpen, Classified

   Oxygen concentrator may melt or catch on fire during use.

   Z-0795-2025 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Fire; Fire

  O2 CONCENTRATOR CAUGHT ON FIRE. THEY PUT THE FIRE OUT AND THERE WERE NO INJURIES. PROPERTY MANAGEMENT FOR THE COMPANY STATED UNIT CAUGHT FIRE IN A RESIDENT'S ROOM IN OUR SKILLED NURSING CARE. THE CONTROL AREA OF THE DEVICE IS WHERE THE FIRE STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694910 ↗
• MalfunctionSep 28, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A CONCENTRATOR CAUGHT ON FIRE IN A PATIENT'S BATHROOM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. THE MANUFACTURER CONTINUES TO REQUEST THE RETURN OF THE DEVICE FOR FURTHER ANALYSIS. IT SHOULD BE NOTED THAT THE MANUFACTURER HAS CONDUCTED INDEPENDENT ELECTRICAL TESTING ON A DEVICE FROM A PROXIMAL LOT AND MONTH, (B)(6) (LOT# JA2311, MANUFACTURE DATE: NOVEMBER 24, 2023), AND DETERMINED THE DEVICE TO MEET ELECTRICAL STANDARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328761 ↗
• MalfunctionSep 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAD A CONCENTRATOR THAT CAUGHT ON FIRE IN A PATIENT'S HOME ON (B)(6) 2024. THE PATIENT HAD NO INJURIES AND DID NOT REQUIRE MEDICAL ATTENTION. THE PATIENT WAS IN A DIFFERENT ROOM FROM THE CONCENTRATOR. THE CONCENTRATOR WAS LOCATED IN THEIR BATHROOM, BECAUSE THEY DID NOT LIKE THE NOISE FROM THE CONCENTRATOR. THE DAUGHTER USED A FIRE EXTINGUISHER TO PUT THE OUT THE FIRE FROM THE CONCENTRATOR. THE FIRE DEPARTMENT WAS CALLED OUT BY THE DAUGHTER AFTER THE FIRE WAS EXTINGUISHED. PER THE DAUGHTER, THE CONCENTRATOR WAS TAKEN BY THE INSURANCE COMPANY. SHE WILL ASK IF SHE CAN GET IT BACK AND LET ME KNOW. THE FAMILY CALLED ME BACK AND THE FIRE INVESTIGATOR HAS THE CONCENTRATOR. THEY JUST SPOKE WITH HIM, AND THEY WILL NOT BE RELEASING THE CONCENTRATOR TO ANYONE. HE SAID THEY WOULD BE HAPPY TO DO A DUAL INVESTIGATION WITH THE MANUFACTURER/COMPANY. THIS EVENT IS NOT CONSIDERED A MANDATORY REPORTABLE EVENT AS THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. THE PRESENCE OR ABSENCE OF A MALFUNCTION CANNOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. HOWEVER, THE MANUFACTURER HAS DECIDED TO MAKE THE FDA AWARE OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256380 ↗
• MalfunctionSep 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AT APPROXIMATELY 11:47PM ON JUNE 25, 2024, AT (B)(6), A FIRE ALARM SOUNDED ON THE 2 SOUTH UNIT IN ROOM 221. THE STAFF RESPONDED AND SAW HEAT AND SMOKE COMING FROM THE OXYGEN CONCENTRATOR, TRUAIRE-5, IN THE ROOM. THE STAFF EVACUATED THE PATIENTS (2) IN ROOM 221 AND THE PATIENTS IN THE ROOMS IN CLOSE VICINITY TO THE DINING ROOM BEYOND THE SMOKE BARRIER DOORS. THE PATIENTS FROM ROOM 221 WERE ASSESSED AFTER THEY WERE EVACUATED AND THERE WERE NO ADVERSE EFFECTS RELATED TO SMOKE INHALATION. AT THE SAME TIME ANOTHER STAFF MEMBER EXTINGUISHED THE FIRE USING THE FIRE EXTINGUISHER. THE FIRE DEPARTMENT RESPONDED AND ARRIVED AT APPROXIMATELY 11:54PM TO CONTAIN AND DISSIPATE THE SMOKE. THERE WAS NO NOTED DAMAGE TO THE STRUCTURE OF THE ROOM, THE TRUAIRE-5 OXYGEN CONCENTRATOR WAS REMOVED FROM THE ROOM, AND THE PATIENTS WERE ABLE TO RETURN TO THEIR ROOMS WITHIN 24 HOURS. THE PATIENT USING THE TRUAIRE-5 AS WELL AS THE OTHER PATIENTS THAT WERE EVACUATED WERE EVALUATED BY A PULMONARY NP THE NEXT DAY, (B)(6) 2024 AND IT WAS NOTED THAT THE PATIENT IN ROOM 221 RESPIRATORY STATUS WAS UNCHANGED AND HER OXYGEN DEMAND WAS STABLE, AND THE OTHER PATIENTS WERE NOTED TO HAVE RESPIRATORY/MENTAL STATUS AT BASELIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256039 ↗