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 | 18980886 |
MDR Text Key | 338687951 |
Report Number | 3012307300-2024-01673 |
Device Sequence Number | 1 |
Product Code |
BTL
|
UDI-Device Identifier | 35019315107263 |
UDI-Public | (01)35019315107263(11)161108 |
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 |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
03/26/2024 |
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 |
Other
|
Device Catalogue Number | P310NUS |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/26/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/29/2024
|
Initial Date FDA Received | 03/26/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/08/2016 |
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 |