FDA Adverse Event
Injury
Summary report: N
HAMILTON T1
MDR report key: 19995931
·
Received August 14, 2024
Report
- Report Number
- MW5158475
- Event Type
- Injury
- Date Received
- August 14, 2024
- Date of Event
- August 11, 2024
- Report Date
- August 12, 2024
- Manufacturer
- HAMILTON MEDICAL, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
VENTILATOR CIRCUIT FAILURE. ALARMING FOR THE FLOW VALVE TO BE FLIPPED WHILE THE VENT WAS ATTACHED TO THE PATIENT.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 9/12/2024 FOR REPORT MW5158475 TO UPDATE PROCODE TO CBK.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5158475 ON 09/18/2024 FOR MANUFACTURER HAMILTON MEDICAL, INC. VENTILATOR CIRCUIT FAILURE. ALARMING FOR THE FLOW VALVE TO BE FLIPPED WHILE THE VENT WAS ATTACHED TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2350676 | HAMILTON T1 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | HAMILTON MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Male | Required Intervention |