FDA Adverse Event
Other
Summary report: N
HAMILTON-T1
MDR report key: 2957236
·
Received January 31, 2013
Report
- Report Number
- 2937708-2013-00001
- Event Type
- Other
- Date Received
- January 31, 2013
- Date of Event
- December 2, 2013
- Report Date
- December 18, 2012
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- PMA / PMN Number
- K120670
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND HAS BEEN EVALUATED. AS ROOT CAUSE WAS DETECTED THAT THE MANUAL DOES NOT INCLUDE INFORMATION ABOUT THE INTERNAL OXYGEN CONSUMPTION OF THE DEVICE DURING USE. A RECALL WAS INITIATED TO PROVIDE THE OPERATOR WITH THIS INFORMATION, REVISE THE OPERATOR'S MANUAL AND IMPLEMENT A SOFTWARE UPDATE WHICH PROVIDES INFORMATION ABOUT OXYGEN CONSUMPTION AND DECREASE THE DEVICE'S OXYGEN CONSUMPTION.
Description of Event or Problem · 1
HAMILTON MEDICAL AG HAS RECEIVED A CUSTOMER COMPLAINT ABOUT AN UNEXPECTED HIGH OXYGEN CONSUMPTION DURING THE VENTILATION OF A SMALL PATIENT WITH THE HAMILTON-T1 VENTILATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41904 | HAMILTON-T1 | TRANSPORT VENTILATOR | CBK | HAMILTON MEDICAL AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |