MAUDE Adverse Event Report: OHIO MEDICAL LLC OHIO MEDICAL INTEGRATED FLOWMETER

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

Ohio medical received medwatch report (b)(4) on march 5, 2020 regarding an alleged product problem with our integrated flowmeter.This report states: "noticed that oxygen was not flowing through flowmeter when being set up for use on a patient.Mfg response for oxygen flowmeter, integrated flowmeter (per site reporter) there is an issue with the oring on devices mfg in 2016.What was the original intended procedure? oxygen delivery what problem did the user have (check all that apply) device failed (e.G.Broke, couldn't get it to work or stopped working)" please see manufacturers response to user facility report below: note: the complaint that was received and noted from this user facility was indicative to the type of malfunction with the integrated flowmeter, however, another device serial number was provided.The serial number referenced on this report cannot be located in any shipment, manufacture, returned material or complaint data.The serial number is believed to be incorrect.The user facility was contacted to obtain the correct serial number, but to date, no response to this request has been received.Upon additional information received from the user facility a follow up report will be submitted.Investigation was performed on this type of malfunction, but not the specific serial number referenced.·extensive tests were performed, and the results have identified that once the flow control knob is torqued past the minimum required force to close (3.54 in-lbf, per iso 15002), a component (fm-seat) will become deformed.Then, when the fm-seat is deformed and while the flow control knob is in motion, a consistent seal cannot be achieved.Although the seat will become deformed after greater than 3.54 in-lbf is applied, once the flow control knob passes an initial rotation the device always displays accurate flow.Internal testing also identified that flow at flood, while not consistent, delivered an average of 29 lpm of oxygen, with the lowest recorded flow at flood being 17 lpm.While this value does not meet our internal specification, iso 15002 does not require a minimum flow at flood.·investigation was performed to determine root cause and it was found that while the device was being manufactured by our sister company (b)(4), the material of the fm-seat was changed from (b)(4) in 2016.·in 2018, material was changed back to (b)(4) due to complaints received.At this time risk was reviewed and it was determined that risk was low, and no further action was required.·as part of this investigation, testing was also performed on devices using (b)(4), and this malfunction does not occur.Furthermore, there have been zero complaints received of this nature for devices manufactured with the (b)(4) fm-seat.Ohio medical contacted two clinical consultants ((b)(4)) for risk review and further recommendations.After clinical review, both consultants agreed that the risk remains low due to flowmeter still delivering accurate flow, and that the average flow at flood remains sufficient for applicable use.Based on this feedback, ohio medical will distribute a field notification alerting customers that devices manufactured with the (b)(4) fm-seat risk deforming the fm-seat component if torqued past the 3.54in-lbf; and if deformed the potential of varying flow levels while attempting to set the device will exist.However once the device is set, the flowmeter will display accurate reading.

• Brand Name: OHIO MEDICAL INTEGRATED FLOWMETER
• Type of Device: INTEGRATED FLOWMETER
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee, il
• Manufacturer (Section G): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee, il
• Manufacturer Contact: jessica barrile ; 1111 lakeside dr; gurnee, il ; 8556318
• MDR Report Key: 9950655
• MDR Text Key: 187968517
• Report Number: 1419185-2020-00007
• Device Sequence Number: 1
• Product Code: CCN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1