Brand Name | V60 VENTILATOR |
Type of Device | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE |
MDR Report Key | 11346390 |
MDR Text Key | 240468692 |
Report Number | 2031642-2021-00658 |
Device Sequence Number | 1 |
Product Code |
MNT
|
UDI-Device Identifier | 00884838089280 |
UDI-Public | (01)00884838089280 |
Combination Product (y/n) | N |
PMA/PMN Number | K102985 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Type of Report
| Initial,Followup |
Report Date |
10/07/2021 |
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 |
No Information
|
Device Model Number | V60 PLUS |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/31/2021 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/25/2021 |
Initial Date FDA Received | 02/18/2021 |
Supplement Dates Manufacturer Received | 09/12/2021
|
Supplement Dates FDA Received | 10/07/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/14/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER |
|
|