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 LOTUS ELECTRONIC CONSERVER OM-700A manufactured by Inovo Inc..
[76524471]
The device reported in this event (conserver, oxygen, product code: nfb, model om-700a, serial number: (b)(4)) was received at inovo's manufacturing facility in (b)(4). This device was tested and analyzed using the device control plan 181. The conserver has visible burn marks at the inlet of the yoke. The cylinder/post valve was not recovered by the customer, so evaluation could not be done. Visible residue was noted along the top side of the flange and sides of the brass inlet filter. No residue is visible in the sintered inlet filter of the brass insert. The seal washer was completely disintegrated leaving only remnants of the brass ring. There were no other burn marks on the exterior of the unit. There are scuff marks found on the yoke, pressure gauge, knob selector, and outlet barb, indicating that the device may have been dropped or mishandled. Analysis indicated that flow friction was most likely the cause, due to a poor connection between the conserver and tank. The root cause could not be conclusively determined based on the fact that no seal washer was submitted. The instructions for use (ifu) states to inspect the sealing surfaces of the oxygen cylinder and the conserver for contamination and damage prior to connecting. The ifu has visual aids to assist in displaying a proper connection. In addition, the ifu states that only one reconnection should be attempted. If a second attempt to connect the device fails, the patient is instructed to not use the device and contact the company they purchased the unit from. This mdr was 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 inovo 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 was reported in an abundance of caution. If inovo becomes aware of additional information that would affect reportability, a supplemental will be submitted. Note that this mdr was previously submitted on 09/06/2016 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
[76524472]
It was reported that the patient was in a vehicle with the cylinder restrained on the back seat of the vehicle and the cylinder valve was turned on. Smoke was smelled and a big bang was heard. The cylinder valve was turned off, but just before turning it off, it was observed that the cylinder was making a loud noise from the oxygen being released. No one was smoking at the time, although both the patient and partner are smokers. There were no reported adverse patient effects. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062191-2017-00002 |
| MDR Report Key | 6602603 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-31 |
| Date of Report | 2015-09-22 |
| Date Mfgr Received | 2015-09-24 |
| Device Manufacturer Date | 2011-10-13 |
| 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 | MS. MARITA BRUST |
| Manufacturer Street | 401 LEONARD BLV. NORTH |
| Manufacturer City | LEHIGH ACRES FL 33971 |
| Manufacturer Country | US |
| Manufacturer Postal | 33971 |
| Manufacturer Phone | 2396436577 |
| Manufacturer G1 | INOVO INC. |
| Manufacturer Street | 401 LEONARD BLV. NORTH |
| Manufacturer City | LEHIGH ACRES FL 33971 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33971 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOTUS ELECTRONIC CONSERVER |
| Generic Name | CONSERVER, OXYGEN, |
| Product Code | NFB |
| Date Received | 2017-05-31 |
| Returned To Mfg | 2016-11-07 |
| Model Number | OM-700A |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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. NORTH LEHIGH ACRES FL 33971 US 33971 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-31 |