MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-03-16 for GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN 0710160 manufactured by Linde Gas North America Llc.
[2071821]
This is a spontaneous medical incident report from a maintenance engineer at a hosp in brazil concerning a (b)(6) male porter at the hosp. On (b)(6) 2011 when the porter tried to open the combilite type (b)(4) cylinder valve (gce combilite i viprs, 5 micron filter, liv for oxygen) of an oxygen cylinder used for transportation a fire started and burnt his hand. The porter had 1st and 2nd degree burns and was assisted in the hosp where he works and was sent home for 5 working days. Treatment given for the burns were aseptic and dressing with silver sulfadiazine. Thereafter he was recovered and is back to work in the same activities as before the incident. Add'l info is expected.
Patient Sequence No: 1, Text Type: D, B5
[9170470]
Investigation is ongoing. Eval: accidental ignition and fire in oxygen valve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2011-00011 |
| MDR Report Key | 2143474 |
| Report Source | 01,06 |
| Date Received | 2011-03-16 |
| Date of Event | 2011-01-29 |
| Date Mfgr Received | 2011-02-14 |
| Date Added to Maude | 2011-06-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 575 MOUNTAIN AVE |
| Manufacturer City | MURRAY HILL NJ 07974 |
| Manufacturer Country | US |
| Manufacturer Postal | 07974 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2011-03-16 |
| Model Number | 0710160 |
| Lot Number | 4195896 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINDE GAS NORTH AMERICA LLC |
| Manufacturer Address | MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-16 |