MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-04-28 for GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN 0710160 manufactured by .
[2071822]
On (b)(6) 2011, linde was initially informed that an incident involving a gce liv valve had occurred in (b)(6) on the same day. No person was injured. While the hosp maintenance personnel was reviewing the cylinder's liv, they perceived that the valve did not work because the oxygen did not leave through the exit unit. According to available info the oxygen cylinder was full. Add'l info is expected.
Patient Sequence No: 1, Text Type: D, B5
[9170471]
Eval: liv valve defect, no pt harm.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2011-00017 |
| MDR Report Key | 2143477 |
| Report Source | 01,06 |
| Date Received | 2011-04-28 |
| Date Mfgr Received | 2011-03-31 |
| Date Added to Maude | 2012-06-11 |
| 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 | (INITIAL UNIT) |
| Manufacturer Country | SW |
| 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 | 2011-04-28 |
| Model Number | 0710160 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-28 |