MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-02-28 for GCE COMBILITE I VIPR, 40 MICRONS TYPE 0710092 FOR OXYGEN manufactured by .
[2574474]
On (b)(6) 2010, linde was initially informed that an incident involving a gce combilite i vipr, 40 microns type (b)(4) for oxygen had occurred in the (b)(6). No person was injured. On (b)(6) 2011, (b)(6) communicated that although a root cause was not identified, similar mechanism for ignition could not be excluded in gce valves of similar design. Therefore (b)(6) 2011, is regarded as the linde awareness date for regulatory reporting of the present incident and despite the fact that this specific valve is not sold in the us the case will be reported to fda. It was reported by (b)(6), that a medical oxygen cylinder had ignited when one of their firemen was performing routine testing of the cylinder. The cylinder had been removed from its bag and visually inspected. On opening the cylinder valve, the operator reported seeing a flame coming from the valve outlet. He then dropped the cylinder, the fire was quickly extinguished using a foam extinguisher.
Patient Sequence No: 1, Text Type: D, B5
[9838503]
(b)(4). Accidental ignition/fire in oxygen valve, not pt/personnel harm. Cause for ignition not known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2011-00031 |
| MDR Report Key | 2507737 |
| Report Source | 01,06 |
| Date Received | 2011-02-28 |
| Date Mfgr Received | 2011-01-31 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2012-04-13 |
| 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 | 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 | 2011-02-28 |
| Model Number | 0710092 |
| Lot Number | 4280965 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-28 |