MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-03-22 for EASY PULSE 5 198705 manufactured by Precision Medical, Inc..
[2597530]
Pt was in church when a fire occurred. Daughter, in turning off oxygen tank suffered burns to her hands
Patient Sequence No: 1, Text Type: D, B5
[9748946]
Precision medical was never contacted that this event occurred, in 2008. There has been pictures taken of the device, and it appears to have not been installed properly on the post valve, which could have caused the incident, put at this time is only speculative in nature, because the device has not been examined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523148-2012-00002 |
| MDR Report Key | 2504840 |
| Report Source | 00 |
| Date Received | 2012-03-22 |
| Date of Report | 2012-03-21 |
| Date of Event | 2008-03-23 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2012-03-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JIM PARKER, QA MGR |
| Manufacturer Street | 300 HELD DR. |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Manufacturer G1 | PRECISION MEDICAL, INC. |
| Manufacturer Street | 300 HELD DR. |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18067 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASY PULSE 5 |
| Generic Name | OXYGEN CONSERVER |
| Product Code | NFB |
| Date Received | 2012-03-22 |
| Model Number | 198705 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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; 2. Deathisabilit | 2012-03-22 |