Brand Name | PORTEX |
Type of Device | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
MDR Report Key | 10877016 |
MDR Text Key | 217437811 |
Report Number | 3012307300-2020-11639 |
Device Sequence Number | 1 |
Product Code |
BTM
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial,Followup |
Report Date |
12/31/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/20/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Date Returned to Manufacturer | 11/06/2020 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/30/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|