Brand Name | PNEUPAC PARAPAC PLUS |
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 | 18402539 |
MDR Text Key | 331602930 |
Report Number | 3012307300-2023-12231 |
Device Sequence Number | 1 |
Product Code |
BTL
|
UDI-Device Identifier | 35019315107263 |
UDI-Public | 35019315107263 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123957 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
12/27/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/27/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | P310NUS |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/11/2023 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/27/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/05/2017 |
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 |
|
|