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 MICRON FILTER, LIV FOR OXYGEN 0710204 manufactured by Linde Gas North America Llc.
[3021199]
On (b)(4) 2008, linde initially received a report concerning an incident happening on the same day at a doctors post in (b)(6). The incident occurred during a demonstration of the use of a conoxia 2 liter liv cylinder in an outside location. After opening the main valve of the cylinder and setting the flow-regulator to 25 l/min a sissing noise was heard followed by a bang and a flash. Flames came out of the valve protection, the medic threw the cylinder clear and the fire extinguished immediately. There was light soot found on the pressure indicator, on valve protection near quick connector and inside valve behind the connector. There were no injuries as a result of the ignition.
Patient Sequence No: 1, Text Type: D, B5
[10436003]
The present case is one out of 9 incident reports in connection with 7b 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 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 | 3003900188-2008-00043 |
| MDR Report Key | 2805472 |
| Report Source | 01 |
| Date Received | 2008-09-22 |
| Date Mfgr Received | 2008-08-11 |
| 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 AVENUE |
| Manufacturer City | MURAY 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 | 2008-09-22 |
| Model Number | 0710204 |
| Lot Number | 2657674 |
| Device Expiration Date | 2017-05-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |