MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2008-09-22 for GCE COMBILITE I VIPRS, 5 MICRO FILTER, LIV FOR OXYGEN 070137 manufactured by Linde Gas North America Llc.
[3022081]
Information was received on (b)(6) 2009, that a client fire brigade in (b)(6) 2009 had observed an ignition of a liv oxygen. As (b)(6) crew put on the cylinder for service (first opening) sparks occurred around the bottom valve opening. The valve was closed, but sparks continued out of the bottom of the valve (assembly shroud and outlet connection). There were no injuries and there is no damage.
Patient Sequence No: 1, Text Type: D, B5
[10252472]
The present case is one out of 9 incident reports in connection with 7 liv ignitions. Evaluation summary: root cause analysis summary: the cause of ignition with highest probability is ignition of hydrocarbons, lubricant and/or debris by adiabatic compression. Potential sources of hydrocarbons and lubricants; lubricant (fomblin) migration, (lubricant from gce manufacturing of valve). Leaching of contaminants (phthalates) from o-rings in valves (lubricant in solvent) and hydrocarbon oil. Leaching of contaminants (phthalates) from fill connector at filling plant at linde potential sources of debris. Debris from manufacturing process of valve at gce. Debris from filling plant at linde. Debris from wear, valves in use. The design (filter and location of components in the high pressure side of the valve) of the gce liv valve 5 micron filter is likely to cause more sensitivity to adiabatic compression heating than the gce oxygen design.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2009-00032 |
| MDR Report Key | 2805492 |
| Report Source | 01 |
| Date Received | 2008-09-22 |
| Date Mfgr Received | 2009-07-17 |
| Date Added to Maude | 2012-10-31 |
| 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 AVENUE |
| Manufacturer City | MURRAY HILL NJ 07974 |
| Manufacturer Country | US |
| Manufacturer Postal | 07974 |
| Single Use | 3 |
| Remedial Action | RC |
| 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 | 2008-09-22 |
| Model Number | 070137 |
| Lot Number | 2980643 |
| Device Expiration Date | 2017-10-30 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2008-09-22 |