MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-07-01 for LINDE INTEGRATED VALVE (LIV) LIV 2000 PSI manufactured by .
[6070536]
This spontaneous medical device incident report, from a customer in usa involves a cylinder linde integrated valve, liv2. No patients were involved. When to use the cylinder, it was found that the cylinder was empty and that nothing came out. The gauge showed full. There were no obvious damage to the outside of the device (guard and cylinder). Device awaiting investigation by a lifegas plant qualified to evaluate. Details of the cylinder involved: product: liv 2,000 psi. Ceodeux lot number: 201209 35. Ceodeux s/n: (b)(4). Additional information is expected.
Patient Sequence No: 1, Text Type: D, B5
[14145825]
Device event, no patient harm, cylinder expected to be full did not deliver gas. Valve under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2015-00004 |
| MDR Report Key | 4890661 |
| Report Source | 00 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-07-01 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-06-04 |
| Date Added to Maude | 2015-07-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | AGAVAGEN 54 |
| Manufacturer City | LIDINGO 181 81 |
| Manufacturer Country | SW |
| Manufacturer Postal | 181 81 |
| Manufacturer G1 | LINDE GAS NORTH AMERICA, INC. |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINDE INTEGRATED VALVE (LIV) |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2015-07-01 |
| Returned To Mfg | 2015-06-08 |
| Model Number | LIV 2000 PSI |
| Lot Number | 201209 35 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-01 |