MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-09-17 for GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN 0710204 manufactured by Linde Gas North America Llc.
[3019797]
On (b)(6) 2008, linde was notified of an incident in connection with the use of a linde integrated valve. On (b)(6) 2008, on arrival of a pt at (b)(6), the assistant anaesthesist was preparing to give the pt medicinal oxygen. The liv 2 l cylinder was mounted on the head outside the bed (vertical position). The assistant anaesthesist opened first the flow-regulator to 15 l/min and opened then the main valve. While connecting the hose/tube to the nipple, an audible hissing sound was heard inside the cap, followed by a flame. All personnel present fled from the area and the cylinder fell on the ground. Shortly after that, a flame came out of the valve, which extinguished after a short time. The fire-alarm was activated and the fire brigade arrived 8 minutes later. There was soot at the beginning of the hose, the mask was clean. During the incident, the pt was unconscious. The assistant anaesthesist suffered of second degree burns (recuperatable) on his hands.
Patient Sequence No: 1, Text Type: D, B5
[10433130]
The present case is one out of 9 incident reports in connection with 7 liv ignitions. Eval 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 mfg 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 mfg 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 | 3003900188-2010-00039 |
| MDR Report Key | 2805401 |
| Report Source | 01,05 |
| Date Received | 2010-09-17 |
| Date of Event | 2008-11-23 |
| Date Mfgr Received | 2008-11-24 |
| Device Manufacturer Date | 2007-05-01 |
| 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 AVE |
| 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 MICRON FILTER, LIV FOR OXYGEN |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2010-09-17 |
| Model Number | 0710204 |
| Lot Number | 2551101 |
| Device Expiration Date | 2017-05-17 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2010-09-17 |