MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-06-14 for EASY PULSE 198705 manufactured by Precision Medical.
[652196]
Daughter changed oxygen tank, placing conserver on a full oxygen tank (a size cylinder), then placing conserver and oxygen tank into a carry bag when the fire started. The fire ignited the carry bag and slightly burned the pt's hand. The pt was taken to the hosp, treated and released.
Patient Sequence No: 1, Text Type: D, B5
[7973762]
Fire occurred after oxygen tank was changed. Failure could of been: end user did not tighten conserver on post valve. Yoke seal was defective between post valve and conserver. Seal on post valve was defective causing particles to hit the yoke seal causing the fire. Conclusion: the conserver was not the cause of the fire. The area around the high pressure inlet, has a black appearance indicating that there was a fire. The post valve attached to the oxygen tank also has corresponding black around the area where the indexing pins and high pressure orifice attach. The filter in the high pressure orifice and the internals of the conserver are clean, showing that the fire did not enter the conserver. The internal parts of the post valve are clean with no indication of fire. The seat on the post valve is damaged or missing, and there are particles in the tank that could be from the seat. The yoke seal is missing. The evidence of the black substance between the conserver and the post valve are indicators of a fire originating at the yoke seal. There was probably a leak at the yoke seal which allowed oxygen to escape. Particles from the tank ignited the yoke seal starting the fire. The fire quickly burned out, after the yoke seal was consumed by the fire, and the high pressure oxygen blew it out. Recommend using yoke seals made of viton and brass, and inspecting the post valves for wear on a frequent basis. (see additional scanned pages).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523148-2007-00001 |
| MDR Report Key | 867482 |
| Report Source | 00 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-06-13 |
| Date of Event | 2007-06-04 |
| Date Mfgr Received | 2007-06-04 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2007-06-22 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JAMES PARKER |
| Manufacturer Street | 300 HELD DRIVE |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASY PULSE |
| Generic Name | OXYGEN CONSERVER |
| Product Code | NFB |
| Date Received | 2007-06-14 |
| Returned To Mfg | 2007-06-11 |
| Model Number | 198705 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 850108 |
| Manufacturer | PRECISION MEDICAL |
| Manufacturer Address | 300 HELD DRIVE NORTHAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-14 |