MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2010-09-17 for GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN 0710160 manufactured by Linde Gas North America Llc.
[2948534]
On (b)(6) 2010, a male nurse ((b)(6) years of age) delivered oxygen to a homecare pt with a chronic asthma attack, and when the cannula was placed, there was a flash that broke the tomagoma of the cylinder. The nurse got a first degree burn in six fingers and was out of work for 10 days. The nurse recovered from the burns.
Patient Sequence No: 1, Text Type: D, B5
[10433127]
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 (b)(4). 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 | 3003900188-2010-00035 |
| MDR Report Key | 2805417 |
| Report Source | 01,04 |
| Date Received | 2010-09-17 |
| Date of Event | 2010-05-28 |
| Date Mfgr Received | 2010-05-31 |
| 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 | 0710160 |
| Lot Number | 4768666 |
| 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 |