Brand Name | AVANCE |
Type of Device | GAS-MACHINE, ANESTHESIA |
Manufacturer (Section D) |
DATEX-OHMEDA INC |
3030 ohmeda drive |
madison WI 53718 |
|
MDR Report Key | 10902522 |
MDR Text Key | 218219283 |
Report Number | 10902522 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
11/24/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | CS2 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/24/2020 |
Device Age | 2 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/25/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/25/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|