Brand Name | HUDSON FOLDABLE MANUAL RESUS,DISP, ADULT W/FLO |
Type of Device | VENTILATOR, EMERGENCY, MANUAL |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
MDR Report Key | 8266732 |
MDR Text Key | 133724247 |
Report Number | 3011137372-2019-00022 |
Device Sequence Number | 1 |
Product Code |
BTM
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Type of Report
| Initial,Followup |
Report Date |
01/07/2019 |
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 Catalogue Number | 5387 |
Device Lot Number | 170717 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/22/2019 |
Initial Date Manufacturer Received |
01/07/2019 |
Initial Date FDA Received | 01/22/2019 |
Supplement Dates Manufacturer Received | 01/31/2019
|
Supplement Dates FDA Received | 02/01/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | NONE REPORTED. |
|
|