MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-11-07 for GCECOMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN 0710137 manufactured by .
[18978396]
An ignition involving a combilite midiflow 25 e rouge oxygen valve (gce combilite i viprs, 5 micron filter, liv for oxygen) occurred on (b)(6) 2011 in (b)(6). No injury to patient or other persons was reported. A male patient treated at home for cluster headache took a cylinder (15 l), opened the valve and selected a 7 l/min flow. Twenty seconds later, the patient heard a noise inside the valve followed by sparks. The patient closed the valve and brought the cylinder outside in his garden. There the cylinder continued to generate sparks. No patient injury. Black deposit on the manodetender and on the patient's tube. On (b)(4) 2011, the valve was shipped to (b)(4) for investigation and analysis. Gce (gas control equipment) is the manufacturer for the present device in europe. The (b)(4) has been informed. (b)(4) has a 510(k) for a similar product. Fda us will be informed.
Patient Sequence No: 1, Text Type: D, B5
[19038333]
Evaluation: spontaneous ignition in gce valve. The valve is under intense investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2011-00029 |
| MDR Report Key | 2329990 |
| Report Source | 01,04 |
| Date Received | 2011-11-07 |
| Date Mfgr Received | 2011-10-10 |
| Date Added to Maude | 2012-07-13 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GCECOMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2011-11-07 |
| Model Number | 0710137 |
| Device Expiration Date | 2013-06-01 |
| Operator | LAY USER/PATIENT |
| 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 | 2011-11-07 |