MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-18 for CYPRESS OM-501 manufactured by Inovo, Inc.
[26226344]
The unit om-501 oxygen conserver and oxygen cylinder were returned to the manufacturer 8/28/2015 and 9/8/2015. The conserver unit was visually inspected and tested under normal conditions. The unit showed no leak or malfunction. All port or barbs were inspected and showed no signs of flash or burn mark penetration. There is no seal washer submitted and the tank had residue on the valve with flash and burn marks.
Patient Sequence No: 1, Text Type: N, H10
[26226345]
Patient daughter stated she was changing an empty tank in the back seat of her car (no damage to car). The oxygen conserver and tank experience a flash fire. She experienced burns to her left hand and went to burn center. She has since recovered and reports no other issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062191-2015-00002 |
| MDR Report Key | 5089561 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-18 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-07-25 |
| Date Mfgr Received | 2015-08-24 |
| Date Added to Maude | 2015-09-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL WOJNOVICH |
| Manufacturer Street | 401 LEONARD BLVD. N. |
| Manufacturer City | LEHIGH ACRES FL 33971 |
| Manufacturer Country | US |
| Manufacturer Postal | 33971 |
| Manufacturer Phone | 2396436577 |
| Manufacturer G1 | INOVO, INC |
| Manufacturer Street | 401 LEONARD BLVD. N. |
| 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 | CYPRESS |
| Generic Name | CONSERVER |
| Product Code | NFB |
| Date Received | 2015-09-18 |
| Returned To Mfg | 2015-08-28 |
| Model Number | OM-501 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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. Other | 2015-09-18 |