Brand Name | CARESCAPE R860 |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
madison, WI 53718 |
|
Manufacturer Contact |
|
MDR Report Key | 9978447 |
MDR Text Key | 214803059 |
Report Number | 2112667-2020-01296 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142679 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
04/20/2020 |
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 | 1506-8600-000 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/24/2020 |
Initial Date FDA Received | 04/20/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/02/2016 |
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 |
|
|