MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-07 for AESTIVA 5 7100 1006-9320-00 manufactured by Datex-ohmeda.
[321143]
Anesthesia machine overheated when servoflurane was used with co2 absorbent (baralyme). Co2 pressure increased, loud pop heard, machine smoked but no fire noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032046 |
| MDR Report Key | 526476 |
| Date Received | 2004-05-07 |
| Date Added to Maude | 2004-05-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | ANESTHESIA MACHINE |
| Product Code | CBL |
| Date Received | 2004-05-07 |
| Returned To Mfg | 2004-05-04 |
| Model Number | AESTIVA 5 7100 |
| Catalog Number | 1006-9320-00 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 516502 |
| Manufacturer | DATEX-OHMEDA |
| Manufacturer Address | * MADISON WI * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-07 |