FDA Adverse Event
Injury
Summary report: N
HAMILTON MEDICAL, INC.
MDR report key: 2536463
·
Received April 10, 2012
Report
- Report Number
- MW5025005
- Event Type
- Injury
- Date Received
- April 10, 2012
- Date of Event
- March 5, 2012
- Report Date
- April 10, 2012
- Manufacturer
- HAMILTON MEDICAL, INC.
- Product Code
- CBK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT WAS ON A HAMILTON MODEL C-2 VENTILATOR. THE VENTILATOR DISPLAYED A 'VENTILATOR CANCELED' MESSAGE AND CEASED PROVIDING VENTILATION TO THE PATIENT. THE PATIENT WAS IMMEDIATELY MANUALLY VENTILATED UNTIL SUCH TIME AS A REPLACEMENT VENTILATOR COULD BE SET UP. NO HARM CAME TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAMILTON MEDICAL, INC. | HAMILTON MEDICAL, INC. C-2 VENTILATOR | CBK | HAMILTON MEDICAL, INC. | C-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DA | Life Threatening| S |