DALTON OXYGEN CONCENTRATOR R-DOC5200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815027012512), received between Aug 30, 2023 and Jan 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Use of Device Problem; Use of Device Problem

  ON 8/1/2024, (B)(6) FROM OUR BUSINESS DEPARTMENT RECEIVED THE AMERICAN CUSTOMER DALTON MEDICA MAIL (FEEDBACK INFORMATION NO.: (B)(4)) FEEDBACK, THAT IS, THERE ARE USERS COMPLAINED ABOUT THE PURCHASE OF OXYGEN CONCENTRATOR PRODUCT FIRE, PRODUCT MODEL: R-DOC5200, SERIAL NUMBER (B)(6), AND PROVIDED THE PICTURES OF THE SHELL OF THE PRODUCT THAT HAD CAUGHT FIRE. AFTER RECEIVING THE EMAIL, LOUIS FROM SALES DEAPRTMENT ASKED DALTON MEDICA BY EMAIL ON 12/1/2024 FOR INFORMATION RELATED TO THIS INCIDENT AS FOLLOWS : A. INQUIRING WHETHER DALTON MEDICA HAS REPORTED THE MDR ACCIDENT REPORT TO THE FDA AND IF SO, WHETHER THE CORRESPONDING MDR INCIDENT REPORT DOCUMENT CAN BE SENT TO US? B. ASKED DALTON MEDICA, DOES THE USERS COULD RETURN THE DEFECTIVE EQUIPMENT? C. WAS THE UNIT BEING TREATED WHEN IT CAUGHT FIRE? WHAT WAS THE USER'S FLOW RATE SETTING? D. WAS THE UNIT BEING TREATED WHEN IT CAUGHT FIRE? WHAT WAS THE USER'S FLOW RATE SETTING? E. WHAT PRODUCT COMPONENTS WERE DAMAGED AFTER THE FIRE IN THE EQUIPMENT? CAN THE EQUIPMENT BE REUSED? F. WAS IT POSSIBLE FOR THE USER TO RETURN THE EQUIPMENT TO US FOR INVESTIGATION AFTER THE FIRE? G. WERE ANY PATIENTS INJURED WHEN THE EQUIPMENT CAUGHT FIRE? H. DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18567979 ↗
• InjuryJan 9, 2024Use of Device Problem; Use of Device Problem

  ON 12/8/2023, DALTON HAS BEEN NOTIFIED BY CUSTOMER (B)(6) OF (B)(6). HE STATED THAT THE OXYGEN CONCENTRATOR THEY PURCHASED FROM DALTON WAS ON FIRE AND PATIENT IS A SMOKER. THE SERIAL NO. OF THE OXYGEN CONCENTRATOR IS (B)(6) . HE DIDN'T RELEASE PATIENT INFORMATION TO US.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479786 ↗
• MalfunctionAug 30, 2023Use of Device Problem; Use of Device Problem

  1) ON (B)(6), 2023, DALTON MEDICAL HAS DONE AN ONSITE INSPECTION AT MEMORIAL HERNAMM HEALTH IN (B)(6), TX. THE INSPECTION INCLUDED THE TRANSFORMER AND INNER MATERIALS. WE TAKEN PHOTOS AND THERE IS NOTHING FOUND WITH THE MACHINE (SEE FILE ATTACHMENT: EVIDENCE 1 OF 1). 2) ON (B)(6), 2023, WE HAVE BEEN NOTIFIED BY THE CUSTOMER: MAX FROM MEMORIAL HERMANN HEALTH SYSTEM OF (B)(6), TEXAS. PER MAX, THEY HAD REPORTED TO FDA REGARDING AN OXYGEN CONCENTRATOR THAT WE SOLD TO THEM CAUGH ON FIRE AT PATIENT SITE THAT DAMAGED THE CARPET (SEE FILE ATTACHMENT: MDR REPORT MW5144602BY THE INITIAL REPORTER). 3) WE ASKED THEM TO PROVIDE US WITH MORE INFORMATION ABOUT THIS INCIDENT. WE WILL ISSUE A UPS CALL-TAG TO GET THE CONCENTRATOR BACK FOR IMMEDIATELY INVESTION BY THE DEVICE MANUFACTURER. 4) MEMORIAL HERMANN HEALTH SYSTEM EMAILED US WITH THE PHOTOS OF OXYGEN CONCENTRATOR RELATING THE INCIDENT. 5 DALTON MEDICAL EMAILED THE PHOTOS TO THE DEVICE MANUFACTURER FOR ANALYSIS. 6) THE DEIVICE MANUFACTURER CONCLUDED THAT THE FIRE COMBUSTION AT THE TIME WAS ON THE OUTER SURFACE OF THE OXYGEN CONCENTRATOR MACHINE BUT NOT THE INTERNAL COMBUSTION OF THE MACHINE. THE DEVICE MANUFACTURER'S REPORT ALSO ASSESSED THE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654798 ↗