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.
[2948989]
This report concerns the second out of three individuals injured in the present incident. Other cases for the same incident are: (b)(6). On (b)(6) 2008, an ambulance in (b)(6) was sent to an emergency situation as a person had jumped out of a window. The person was still alive when the ambulance arrived at the scene and one of the paramedics wanted to give medicinal oxygen treatment (normal procedure) to the pt. When the paramedic opened the main valve of the conoxia 2 liter liv cylinder a loud bang was heard and an oxygen flame came out of the conoxia cylinder. The oxygen flame went through the three layers of cloths that the paramedic was wearing and resulted in burn wounds to his breast (size of a handball) and arm. Two policemen that were at the scene were also slightly injured (injuries unk) the paramedic threw away the cylinder after the incident and was taken, together with the pt, to the nearest hospital (around 5 minutes from the scene. The paramedic was treated in the hosp for his burn wounds (mainly 1st but also 2nd degree) and could return to his home later that night. All the injured persons could leave the hosp after nursing at the first aid department.
Patient Sequence No: 1, Text Type: D, B5
[10257143]
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)(6). 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 | 3003900188-2010-00037 |
| MDR Report Key | 2805403 |
| Report Source | 01,05 |
| Date Received | 2010-09-17 |
| Date of Event | 2008-08-01 |
| Date Mfgr Received | 2008-08-02 |
| 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 | 2551116 |
| Device Expiration Date | 2017-05-22 |
| 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 |