MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2008-05-30 for manufactured by .
| Report Number | 8010042-2008-00068 |
| MDR Report Key | 1103623 |
| Report Source | 01,05,06,08 |
| Date Received | 2008-05-30 |
| Date Mfgr Received | 2008-05-22 |
| Date Added to Maude | 2008-08-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JAMIE YIEH |
| Manufacturer Street | 1140 ROUTE 22 E, STE 202 |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089472311 |
| Manufacturer G1 | MAQUET CRITICAL CARE AB |
| Manufacturer Street | * |
| Manufacturer City | * S-171 54 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | S-171 54 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MOD |
| Date Received | 2008-05-30 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1082877 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-30 |