Brand Name | PURITAN BENNETT 840 VENTILATOR |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
COVIDIEN LP / MEDTRONIC |
15 hampshire street |
mansfield MA 02048 |
|
MDR Report Key | 10762251 |
MDR Text Key | 213891095 |
Report Number | 10762251 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial,Followup |
Report Date |
10/26/2020,08/04/2020 |
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
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/26/2020 |
Date Report to Manufacturer | 10/30/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/30/2020 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/27/2022
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 9855 DA |
Patient Sex | Male |
|
|