MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2011-12-28 for GCE COMBILITE I VIPR, 40 MICRONS TYPE 0710092 FOR OXYGEN COMBILITE TYPE 4 manufactured by .
[2399011]
This is an initial spontaneous incident report found in a newspaper in the (b)(6) concerning a female pt, of unk age, hospitalised in an intensive care unit. The initial information on this incident was received on (b)(4) 2011 but the type of valve was not communicated to the company until on (b)(4) 2011 an oxygen cd cylinder was used for providing respiratory oxygen while transferring the pt. The oxygen cylinder was placed between the pt's legs on the bed for transfer. When the valve, a gce combilite i vipr, 40 microns (combilite type 4 (boc part number 19317500)) for oxygen, was turned on, blue flames were seen coming out of the outlet. This caused 18% burns (both legs) to the pt and burns on the bed and the floor. The pt was transferred to the burns unit at (b)(6) hospital. The current condition of the pt is unk. The burns were assessed as a medically significant event. The valve is with (b)(4) health and safety executive for investigations. Linde gas north america llc has a 510 (k) for a similar, but not identical, product. Fda us will be informed. Additional information is expected.
Patient Sequence No: 1, Text Type: D, B5
[9683282]
Accidental spontaneous oxygen valve ignition causing severe burns requiring burn unit therapy. The valve is undergoing intensive and extensive investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2011-00030 |
| MDR Report Key | 2396786 |
| Report Source | 00,01 |
| Date Received | 2011-12-28 |
| Date Mfgr Received | 2011-11-29 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2012-01-04 |
| 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 Country | SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GCE COMBILITE I VIPR, 40 MICRONS TYPE 0710092 FOR OXYGEN |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2011-12-28 |
| Model Number | COMBILITE TYPE 4 |
| Lot Number | 4411485 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-28 |