Brand Name | HAMILTON MEDICAL AG |
Type of Device | HAMILTON-C6 VENTILATOR |
Manufacturer (Section D) |
HAMILTON MEDICAL AG |
via crusch 8 |
bonaduz, switzerland 7402 |
SZ 7402 |
|
Manufacturer Contact |
daniel
elice
|
via crusch 8 |
bonaduz, switzerland 7402
|
SZ
7402
|
|
MDR Report Key | 18911108 |
MDR Text Key | 337737543 |
Report Number | 3001421318-2024-00629 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 07630002808590 |
UDI-Public | 07630002808590 |
Combination Product (y/n) | N |
Reporter Country Code | NO |
PMA/PMN Number | K201658 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/15/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/15/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 160021 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/04/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|