MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-07-27 for GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN manufactured by .
[2130557]
An ignition involving a gce liv oxygen valve (gce combilite i viprs, 5 micron filter, liv for oxygen) occurred on (b)(6) 2011 at (b)(6) hospital centre in (b)(6). No injury to pts or hosp staff was reported. Based on preliminary info, it appears that the ignition occurred when hosp staff was connecting a hose to the quick connector of the valve. During the transfer of the pt through the emergency entrance, the physician picked up a 5 l liv oxygen cylinder from the stock and came back to the ambulance. Inside the ambulance, the doctor removed the tamper proof evidence (the transparent bag), disconnected the respiratory hose from respiratory vehicle supply and opened the shut off valve (sov). He has taken the hose of the respirator device and has "made closer" the quick connection to the low pressure outlet. When the straight hose connection touched the vipr, a spark occurred. Despite the spark, carried away by the "elan", he has plugged but not locked the quick connection to the low pressure outlet. He heard a "vent noise" followed by a brief explosion with a yellow almost white flame. The ignition caused a small burn to the doctor's pants. The hose was ejected from the valve outlet, the cylinder purged itself through the respiratory hose and fell to the floor of the emergency vehicle. The valve and the hose will be shipped to (b)(4) for investigation. Add'l info is expected. (b)(4) is the mfr for the present device in (b)(4). (b)(4) has a 510(k) for a similar product.
Patient Sequence No: 1, Text Type: D, B5
[9215539]
Accidental spontaneous ignition in oxygen valve. The device is under investigation and analysis for root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2011-00028 |
| MDR Report Key | 2192813 |
| Report Source | 01,05 |
| Date Received | 2011-07-27 |
| Date Mfgr Received | 2011-06-27 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2011-08-08 |
| 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 | 0 |
| 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 | 0 |
| 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 | 2011-07-27 |
| Lot Number | 9/896335267401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-27 |