Brand Name | HUDSON AQUATHERM III,ELECTRONIC HEATER |
Type of Device | HEATER, BREATHING SYSTEM W/WO |
MDR Report Key | 10683443 |
MDR Text Key | 211502799 |
Report Number | 3003898360-2020-00863 |
Device Sequence Number | 1 |
Product Code |
BZE
|
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 |
09/24/2020 |
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 | 050-14 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
09/24/2020 |
Initial Date FDA Received | 10/15/2020 |
Supplement Dates Manufacturer Received | 10/06/2020
|
Supplement Dates FDA Received | 10/19/2020
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | NEBULIZER; NEBULIZER; NEBULIZER |
|
|