FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C6
MDR report key: 19872489
·
Received July 31, 2024
Report
- Report Number
- 3001421318-2024-01824
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- July 11, 2024
- Report Date
- October 4, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE BIOMED SAYS THE UNIT WAS COMING UP WITH A "OXYGEN SUPPLY FAILURE". HE HAS EVEN TRIED THE UNIT ON A O2 CYLINDER TO ENSURE IT WAS NOT THE HOSPITAL SUPPLY. PLEASE ADVISE HIS NEXT STEPS. NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE BIOMED SAYS THE UNIT WAS COMING UP WITH A "OXYGEN SUPPLY FAILURE". HE HAS EVEN TRIED THE UNIT ON A O2 CYLINDER TO ENSURE IT WAS NOT THE HOSPITAL SUPPLY. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 984322 | HAMILTON-C6 | HAMILTON-C6 | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |