MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-04 for PRECSION MEDICAL INC. EP5 198705 manufactured by Precision Medical Inc..
[16217676]
Fire involving a oxygen conserver and oxygen tanks. Patient (b)(6) was slightly injured, did not require medical attention. Trailer had fire and smoke damage. At this time unknown cause for the fire, evidence indicates possible smoking by patient.
Patient Sequence No: 1, Text Type: D, B5
[16578240]
Reported that there was a fire with a conserver. No reportable injuries, but fire and smoking damage, to dwelling. Photos of conserver were sent, showing fire damage, but the conserver and tanks have not been inspected by us.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523148-2013-00004 |
| MDR Report Key | 3381555 |
| Report Source | 07 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-09-04 |
| Date of Event | 2013-08-14 |
| Report Date | 2013-09-04 |
| Date Reported to Mfgr | 2013-09-04 |
| Date Mfgr Received | 2013-08-30 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2013-10-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JIM PARKER |
| Manufacturer Street | 300 HELD DR. |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECSION MEDICAL INC. |
| Generic Name | OXYGEN CONSERVER |
| Product Code | NFB |
| Date Received | 2013-09-04 |
| Model Number | EP5 |
| Catalog Number | 198705 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL INC. |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-04 |