MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2014-04-04 for LIV SYSTEM WITH GCE - VIPR VALVE manufactured by .
[4382675]
Spontaneous ignition of a liv system with gce vipr valve from year 2009 reported (b)(6) 2014 from a (b)(6). No patients came to harm. Vipr serial number (b)(6). Filed 2014 in the (b)(6). Iv 1000 conoxia cylinder had a barcode (b)(6). A patient was treated at the emergency ward at a hospital in (b)(6). The patient was connected to the heart defibrillator. The patient needed oxygen and the hose of the oxygen mask was attached to the oxygen cylinder. When attaching the lug of the cone of the oxygen bottle there was an immediate and loud bang and flames and a pressure wave. A massive hissing from the oxygen bottle was heard. The fire went to the defibrillator and its cable mounted on the device over. The patient was immediately taken out of the room. No patients or staff came to harm. The cylinder will be picked up for investigation. Additional information is expected.
Patient Sequence No: 1, Text Type: D, B5
[11903403]
Evaluation: accidental spontaneous ignition in oxygen valve. Root cause unknown, investigations ongoing. Main manufacturer informed and involved in the analysis process. (b)(6) informed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2014-00002 |
| MDR Report Key | 3808205 |
| Report Source | 00,01,05 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-04-04 |
| Date Mfgr Received | 2014-03-14 |
| Date Added to Maude | 2014-05-23 |
| 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 Country | SW |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIV SYSTEM WITH GCE - VIPR VALVE |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2014-04-04 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-04 |