MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-31 for EVOLUTION ELECTRONIC CONCERVER OM-904J manufactured by Inovo. Inc.
[76377303]
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.
Patient Sequence No: 1, Text Type: N, H10
[76377304]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062191-2017-00004 |
| MDR Report Key | 6603059 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-31 |
| Date of Report | 2015-08-14 |
| Date Mfgr Received | 2015-11-25 |
| Device Manufacturer Date | 2015-03-16 |
| Date Added to Maude | 2017-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARITA BURST |
| Manufacturer Street | 401 LEONARD BLVD. N |
| Manufacturer City | LEHIGH ACRES FL 33971 |
| Manufacturer Country | US |
| Manufacturer Postal | 33971 |
| Manufacturer Phone | 2396436577 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOLUTION ELECTRONIC CONCERVER |
| Generic Name | EVOLUTION ELECTRONIC CONCERVER |
| Product Code | NFB |
| Date Received | 2017-05-31 |
| Returned To Mfg | 2015-12-14 |
| Model Number | OM-904J |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INOVO. INC |
| Manufacturer Address | 401 LEONARD BLVD. N LEHIGH ACRES FL 33971 US 33971 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-31 |