Brand Name | VOCSN |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
VENTEC LIFE SYSTEMS, INC |
22002 26th ave se |
bothell WA 98021 |
|
Manufacturer (Section G) |
VENTEC LIFE SYSTEMS, INC |
22002 26th ave se |
|
bothell WA 98021 |
|
Manufacturer Contact |
elizabeth
gilbert
|
22002 26th ave se |
bothell, WA 98021
|
4256861765
|
|
MDR Report Key | 18136739 |
MDR Text Key | 328128735 |
Report Number | 3013095415-2023-00722 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00855573007747 |
UDI-Public | 0100855573007747 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162877 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
10/18/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/14/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | PRT-01100-000 |
Device Catalogue Number | PRT-01100-000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/01/2023 |
Date Manufacturer Received | 10/18/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/20/2019 |
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 |
|
|