Brand Name | PNEUPAC VENTILATORS VR1 STANDARD |
Type of Device | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan ln n |
minneapolis MN 55442 |
|
Manufacturer Contact |
reed
covert
|
6000 nathan lane north |
minneapolis, MN 55442
|
2247062300
|
|
MDR Report Key | 18480459 |
MDR Text Key | 332879739 |
Report Number | 3012307300-2024-00177 |
Device Sequence Number | 1 |
Product Code |
BTL
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | UNKNOWN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/19/2024 |
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 Catalogue Number | VR1STDNJJP |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 12/14/2023 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/11/2023 |
Initial Date FDA Received | 01/09/2024 |
Supplement Dates Manufacturer Received | 01/21/2024
|
Supplement Dates FDA Received | 02/19/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/14/2022 |
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 |
|
|