MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-09-30 for GCE COMBILITE I VIPRS, 5 MICRO FILTER, LIV FOR OXYGEN manufactured by .
[3791901]
This is a spontaneous medical device incident report from a physician concerning an ignition in a conoxia go2x 5 l aluminum cylinder with gce liv (linde integrated valve, 5 micron filter) valve. Model ventil combilite lgt 25 e maxiflow lgt din (b)(4). The incident occurred at the intensive care unit (icu) of the (b)(6) hospital at (b)(6). A pt should be brought to operation theatre. In this icu one gas cylinder is stored in a cart (creeper/dolly) and is reserved for emergencies. The 5 l cylinder was taken from the cart and hanged on the foot side of the bed with bed hangers on the cylinder guard. The nose cannula was connected to the flow outlet of the cylinder. The nose cannula was not yet connected to the pt. First the shut-off valve was turned open (normally one and a half turn). The intention was to set the flow at 3 l/min. This was done. Then a very loud sound occurred, to be heard in the next room. Immediately after a flame appeared first on the side of the cylinder, immediately after this flames around the whole guard emerged. It was reported that the flames went in downside direction. The guard was melted and the cylinder dropped from the foot-end of the bed to the floor. First a wet towel was thrown over the burning cylinder. Then water from the sink nearby was poured over the burning cylinder. First flames came still out of the cylinder and then stopped. When the physician arrived with the fire extinguisher the fire was already stopped. The smoke by the burning cylinder caused a fire alarm. The police and firemen arrived shortly after at the hospital. The pt was transferred in another bed to the operation theatre. When cleaning up the concerned room, a nurse touched the bed at the foot-end and got second degree burns on her hand. This happened several minutes after the fire was extinguished. Another nurse who attended the scene of the burning cylinder got an asthma attack, maybe caused by the smoke and the agitation of the event. The valve was in use since (b)(6) 2010. The cylinder with this valve was filled with medical oxygen 12 times, always at the same filling station. Last filling date was (b)(6) 2013. The suspected valve has been purged in (b)(6) 2012 at (b)(6). The valve has been sent to (b)(4) for analysis.
Patient Sequence No: 1, Text Type: D, B5
[11343940]
Evaluation: accidental spontaneous ignition in oxygen valve, no pt harm. Valve sent for investigation. Reported to main manufacturer and authorities in accordance to regulations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2013-00001 |
| MDR Report Key | 3432092 |
| Report Source | 01,05,06 |
| Date Received | 2013-09-30 |
| Date of Report | 2013-09-30 |
| Date of Event | 2013-08-30 |
| Date Mfgr Received | 2013-08-30 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2013-10-29 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Country | SW |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GCE COMBILITE I VIPRS, 5 MICRO FILTER, LIV FOR OXYGEN |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-30 |