FDA Adverse Event
Summary report: N
HAMILTON C-2
MDR report key: 2992255
·
Received February 27, 2013
Report
- Report Number
- 2992255
- Date Received
- February 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- HAMILTON MEDICAL
- Product Code
- CBK
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
BEGINNING IN 2011, THE C2 HAMILTON VENT WOULD MALFUNCTION DURING PATIENT USE AND SHOW A TECHNICAL FAILURE OF 244011. ALTHOUGH THE VENTS WERE REPEATEDLY TESTED, THE ERROR WAS NEVER ABLE TO BE REPRODUCED. WE TRACKED THIS ISSUE BEGINNING IN JUNE 2012 AFTER SEVERAL 244011 ERROR MESSAGES. ALTHOUGH THERE HAVEN'T BEEN ANY RECENT OCCURRENCES (LAST NOTED IN AUGUST 2012), THERE HAS NOT BEEN AN EXPLANATION FROM THE MANUFACTURER AS TO THE ORIGIN OF THE ERROR. REPORT IS BEING MADE AS A PRECAUTION DUE TO THE UNKNOWN ORIGIN OF THE ERROR MESSAGE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83823 | HAMILTON C-2 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | HAMILTON MEDICAL | C-2 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |