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.
[2944421]
On (b)(6) 2008, linde was initially informed that an incident involving liv maxiflow 2 liters had occurred in the (b)(6) 2008. No people were injured by the accident. An ambulance in (b)(6), was sent to an incident where a patient was lying on a terrace. One of the paramedics wanted to give medicinal oxygen treatment to the patient and connected a hose to the hose barb of the liv cylinder in horizontal position. Shortly after opening the main valve of the conoxia 2 liter liv cylinder and setting the flow-regulator to 12 l/min, a big bang was heard and a flame came out of the conoxia cylinder. The paramedic closed the main shut off valve immediately and disconnected the patient. A policeman at the scene extinguished the fire (according to spectators). There was soot inside the hose and mask and it is unknown if the patient inhaled any of the soot. There were no injuries as a result of the ignition.
Patient Sequence No: 1, Text Type: D, B5
[10432308]
The present case is one out of 9 incident reports in connection with 7b liv ignitions. Evaluation summary: root cause analysis: 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 | 3003900188-2008-00042 |
| MDR Report Key | 2805490 |
| 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 | 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 | 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 |