FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C6
MDR report key: 24604493
·
Received March 16, 2026
Report
- Report Number
- 3001421318-2026-00137
- Event Type
- Malfunction
- Date Received
- March 16, 2026
- Date of Event
- February 14, 2026
- Report Date
- March 16, 2026
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG REF NR: (B)(4).
Description of Event or Problem · 0
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "CUSTOMER STATES USER SMELLED BURNING DURING USE AND BROUGHT THE UNIT TO BIOMED. USER STATES "WHILE NEBULIZING A MEDICATION VIA INTERNAL AEROGEN, IT STARTED TO SMELL". NO PATIENT HARM, VENTILATOR WAS PULLED FORM SERVICE. UNIT RETURNED TO BOMIMED TO INSPECT. UPON INSPECTION OF UNIT, FOUND COMPONENT ON MAIN BOARD BURNED. EXAMINED ALL PARTS IN VU SECTION OF VENTILATOR, NO OTHER EVIDENCE OF BURNING." NO HEALTH CONSEQUENCES OR IMPACT AND NO INTERVENTION NECESSARY. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663353 | HAMILTON-C6 | HAMILTON-C6 | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |