FLOWMETER, THORPE FM-T-15UORecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00628101503000), received between Feb 21, 2021 and Apr 23, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 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.

• MalfunctionApr 23, 2025Improper Flow or Infusion; Improper Flow or Infusion

  ON MARCH 24, 2025, OHIO MEDICAL RECEIVED A MEDSUN FDA-3500A FORM SUBMITTED BY THE USER FACILITY REGARDING AN INCIDENT THAT OCCURRED ON (B)(6) 2025. THE REPORT STATED, "PATIENT WAS ON BIPAP [BILEVEL POSITIVE AIRWAY PRESSURE]; RN [REGISTERED NURSE] CALLED CHARGE RN TO REPORT PATIENTS O2 SATURATION WAS DROPPING FROM 95% TO 88%. UPON ARRIVAL BIBPAP MACHINE SAID "NO O2 FLOW," CHARGE RN CHECKED THE WALL O2 OUTLET AND DISCOVERED THE O2 FLOW METER IN ROOM WAS NOT WORKING AND SWITCHED O2 FLOW METER ON OTHER SIDE OF WALL." THE AFFECTED DEVICE WAS ORIGINALLY SHIPPED ON JUNE 29, 2020. ACCORDING TO THE REPORT, THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT. OHIO MEDICAL REVIEWED OUR COMPLAINT DATABASE AND DETERMINED THAT THIS FAILURE HAD NOT BEEN REPORTED TO US. WE THEN INITIATED (B)(4) TO BRING SUSPECT DEVICE, OHIO MEDICAL AMVEX FLOWMETER (SERIAL #(B)(6)) BACK IN HOUSE FOR EVALUATION. MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE BY THE REGISTERED NURSE PATIENT SAFETY COORDINATOR, (B)(6), TO HAVE THE FLOWMETER RETURNED FOR EVALUATION. DESPITE THESE EFFORTS, THE USER FACILITY DID NOT PROVIDE THE DEVICE AND C

  Patient problems: Low Oxygen Saturation

  MAUDE report 21895100 ↗
• DeathFeb 21, 2021Defective Component; Therapeutic or Diagnostic Output Failure

  OHIO MEDICAL WAS NOTIFIED BY (B)(6) OF THE SUPPLY CHAIN OPERATIONS DEPARTMENT AT (B)(6) MEDICAL CENTER THROUGH OUR NORMAL COMPLAINT COLLECTION PROCESS ON (B)(6) 2021, OF AN ADVERSE EVENT THAT OCCURRED INVOLVING A FLOWMETER WITH POWER TAKE-OFF ADAPTER ASSEMBLY. THE BRIEF DESCRIPTION OF THE INCIDENT PROVIDED WAS "POWER TAKE-OFF WAS NOT FUNCTIONING". OHIO MEDICAL SERVICE ADMINISTRATOR (B)(4) ATTEMPTED TO CONTACT (B)(6) MEDICAL CENTER ON (B)(4) 2021, BY EMAIL FOR FURTHER INFORMATION BECAUSE THE COMPLAINT INDICATED THAT THE PRODUCT CONTRIBUTED TO DEATH, ILLNESS, OR SERIOUS INJURY, AND ALSO TO DETERMINE WHEN THE DEVICE WOULD BE RETURNED FOR EVALUATION. THESE ATTEMPTS WERE UNSUCCESSFUL AS ALL CONTACTS AT (B)(6) MEDICAL CENTER FAILED TO RESPOND. ON (B)(4) 2021, OHIO MEDICAL SR. QUALITY ASSURANCE MANAGER (B)(4) SPOKE WITH THE RISK MANAGER, (B)(6) AT (B)(6) MEDICAL CENTER AND SHE CONFIRMED THAT THE FLOWMETER ASSEMBLY DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. THIS TELEPHONE CONVERSATION WAS SUBSEQUENTLY CONFIRMED ON (B)(4) 2021, VIA EMAIL BY (B)(6) MEDICAL CENTER RISK MANAGER (B)(6). ON FEBRUARY 10, 2021, OHIO MEDICAL RECEIVED USER FACILITY MEDWATCH REPORT (B)(4) VIA (B)(6). MEDWATCH

  Patient problems: Death

  MAUDE report 11356688 ↗