MAUDE Adverse Event Report: OHIO MEDICAL LLC AMVEX FLOWMETER

Model Number	FM-T-15UO
Health Effect - Clinical Code	Death (1802)
Date of Event	01/17/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Ohio medical evaluated existing flowmeter assemblies in stock and no abnormalities or defects were found.Due to the inconsistencies in information provided from (b)(6) medical center's communications, ohio medical will investigate further.
Event or Problem Description
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 report contained a description of the event that was inconsistent with what had previously been reported to ohio medical by (b)(6) medical.Upon receiving medwatch report whose details conflicted with what had been previously reported, ohio medical sr.Quality assurance manager (b)(4) contacted (b)(6) medical center on february 11, 2021, and february 16, 2021, to clarify the inconsistency of information reported.On february 18, 2021, (b)(6) medical center risk manager (b)(6) responded via email that the user facility medwatch report (b)(4) was submitted on january 25, 2021, with the information that was available at that time.Upon discussion with ohio medical on january 27, 2021, additional information had been obtained.(b)(6) medical center risk manager also stated in the february 18th email that they might send an addendum to report (b)(4) to reflect facts known as of january 27, 2021.Ohio medical has requested the flowmeter with power take-off adapter assembly be returned to confirm that the device performed to specification and as intended.On february 19, 2021, (b)(6) medical center risk manager (b)(6) communicated to ohio medical via email that the device has been sequestered and will not be returned; therefore, ohio medical is assessing if an on-site visit to evaluate the device is possible.In this same email communication on february 19, 2021, (b)(6) medical center risk manager has now stated that a combination of the flowmeter assembly and oxygen source contributed to the event.Flowmeters are dependent on a consistent and stable oxygen source.If the facility has issues with its oxygen source oxygen dependent devices are at risk of failure.

• Brand Name: AMVEX FLOWMETER
• Common Device Name: FLOWMETER
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• MDR Report Key: 11356688
• Report Number: 1419185-2021-00002
• Device Sequence Number: 715176
• Product Code: CAX
• UDI-Device Identifier: 00628101503000
• UDI-Public: 00628101503000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FM-T-15UO
• Device Catalogue Number: FM-15UO-OHPT-S
• Device Lot Number: T15UO20157
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death