Brand Name | CARESCAPE R860 |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
madison, WI 53718 |
|
Manufacturer (Section G) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
|
madison, WI 53718 |
|
Manufacturer Contact |
anthony
amenson
|
3030 ohmeda drive |
madison, WI 53718
|
|
MDR Report Key | 18992307 |
MDR Text Key | 338910701 |
Report Number | 2112667-2024-01669 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00840682102346 |
UDI-Public | (01)00840682102346(11)161117 |
Combination Product (y/n) | N |
Reporter Country Code | TC |
PMA/PMN Number | K210384 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
07/22/2024 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/28/2024 |
Initial Date FDA Received | 03/28/2024 |
Supplement Dates Manufacturer Received | 07/03/2024
|
Supplement Dates FDA Received | 07/22/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/17/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
|
|