MAUDE Adverse Event Report: INOVO. INC EVOLUTION ELECTRONIC CONCERVER

Model Number	OM-904J
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device reported in this event (conserver, oxygen, product code: nfb, model number: cm-904j, serial number:(b)(4)) was received on 12/14/2015 at enovors manufacturing facility in (b)(4).The device was tested using the device control plan 755.Et was determined that the piezo (festo) valve (part number: 3000412) was defective and was causing the device to not pulse.In addition it was noted that the printed circuit board assembly (pcba) (part number: 4000276-alarm) was damaged, but even with the damaged pcba, there was still electrical power to the valve.The piezo (festo) valve and pcba were replaced and the device performed to specifications as described in the device control plan 755.Attempts to gather additional information were unsuccessful, so a causal relationship between the device malfunction and the necessity to transport the patient to the hospital could not be made.The device is not intended for treatment or diagnosis of disease process.In addition, the device is not intended to be life saving or life sustaining, but to provide supplemental oxygen to the patient.The device has a feature where the patient can bypass the conserve mode to continuous flow.The bypass prevents the patient from receiving no oxygen if conserve mode is not functioning.[t is unknown if the patient attempted to use continous flow.(b)(4).This mdr is being submitted as a result of a voluntary two-year retrospective review that was performed to identify potentially reportable complaints.There was no report that an [novo device caused or contributed to an adverse event where death, serious injury, or a significant public health hazard has occurred or may occur if the alleged malfunction were to reoccur; however, this event is being reported in an abundance of caution.If [novo becomes aware of additional information that would affect reportability, a supplemental will be submitted.Note that this mdr was previously submitted on 01/28/2017 and is being re-submitted because it was not fully processed or received by fda due to an error.
Event or Problem Description
It was reported that the patient was not receiving oxygen while in the conserve mode and the device is displaying a constant blinking light.The patient was transported to the hospital for an unknown reason.The status of the patient is unknown at this time.Multiple attempts to gather additonal information were unsucessful.

• Brand Name: EVOLUTION ELECTRONIC CONCERVER
• Common Device Name: EVOLUTION ELECTRONIC CONCERVER
• Manufacturer (Section D): INOVO. INC; 401 leonard blvd. n; lehigh acres FL 33971
• MDR Report Key: 6603059
• Report Number: 1062191-2017-00004
• Device Sequence Number: 767785
• Product Code: NFB
• UDI-Device Identifier: 00814470020198
• UDI-Public: 00814470020198
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/14/2015

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?: Yes
• Operator of Device: No Information
• Device Model Number: OM-904J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2015
• Initial Report FDA Received Date: 05/31/2017
• 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: Required Intervention