Brand Name | AESPIRE 7900 |
Type of Device | ANESTHESIA GAS MACHINE |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda drive |
madison 53718 |
|
Manufacturer (Section G) |
DATEX-OHMEDA, INC. |
3030 ohmeda drive |
|
madison 53718 |
|
Manufacturer Contact |
john
szalinski
|
540 w. northwest highway |
barrington, IL 60010
|
|
MDR Report Key | 6010800 |
MDR Text Key | 56800662 |
Report Number | 2112667-2016-01961 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
PMA/PMN Number | K050626 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
11/29/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/07/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/07/2016 |
Date Device Manufactured | 01/01/1970 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|