MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2004-11-05 for SERVO VENTILATOR 300 6079391 E380E manufactured by Maquet Critical Care Ab.
| Report Number | 8010024-2004-00010 |
| MDR Report Key | 828819 |
| Report Source | 06,07,08 |
| Date Received | 2004-11-05 |
| Date of Report | 2004-11-05 |
| Date of Event | 2004-09-26 |
| Date Facility Aware | 2004-10-27 |
| Report Date | 2004-11-05 |
| Date Mfgr Received | 2004-10-01 |
| Date Added to Maude | 2007-03-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMIE YIEH |
| Manufacturer Street | 1140 ROUTE 22 EAST 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 | SOLNA S-171 95 |
| Manufacturer Country | * |
| Manufacturer Postal Code | S-171 95 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERVO VENTILATOR 300 |
| Generic Name | RESPIRATORY VENTILATOR |
| Product Code | LSS |
| Date Received | 2004-11-05 |
| Model Number | 6079391 |
| Catalog Number | E380E |
| Lot Number | NA |
| ID Number | * |
| Device Availability | * |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 816207 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | * SOLNA * |
| Baseline Brand Name | SERVO VENTILATOR 300 |
| Baseline Generic Name | RESPIRATORY VENTILATOR |
| Baseline Model No | 6079391 |
| Baseline Catalog No | E380E |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-05 |