MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-03-21 for GCE COMBILITE VALVE, CYLINDER 241955 manufactured by .
[20264773]
Ignition in gce combilite valve on (b)(6) 2014 at the filling site in (b)(6). No patients were involved as the incident occurred at the filling site. Cylinder was sent to (b)(6) for further investigation. Process to investigate root cause and elimination of reoccurrence has been initiated by working together with gce. Gce (gas control equipment) is the manufacturer for the present device is europe. (b)(6) has a 510 (k) for a similar product. Cylinder serial number: (b)(4), dom: 05/01/2013, valve number: 090798217, dom: (b)(6) 2009. Expiry date: 11/26/2016. Assessment report state that incident could have occurred when the customer used it next. As the cylinder had been returned to boc for re-filling, and had not been inspected prior to the ignition occurring, there is no evidence if the cylinder had been previously used by the customer or whether there was any external evidence of damage or contamination before the valve was inadvertently turned on.
Patient Sequence No: 1, Text Type: D, B5
[20480789]
Accidental spontaneous ignition of oxygen valve. Extensive investigation in collaboration with valve manufacturer. No patient or personnel harm.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2014-00001 |
| MDR Report Key | 3799627 |
| Report Source | 01,07 |
| Date Received | 2014-03-21 |
| Date of Report | 2014-03-21 |
| Date of Event | 2014-01-12 |
| Date Mfgr Received | 2014-01-29 |
| Date Added to Maude | 2014-07-21 |
| 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 |
| Manufacturer G1 | LINDE GAS NORTH AMERICA LLC |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GCE COMBILITE VALVE, CYLINDER |
| Generic Name | NA |
| Product Code | ECX |
| Date Received | 2014-03-21 |
| Model Number | 241955 |
| ID Number | 090798217 |
| Device Expiration Date | 2003-05-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-21 |