FDA Adverse Event
Summary report: N
VIASYS
MDR report key: 2954015
·
Received January 29, 2013
Report
- Report Number
- 2954015
- Date Received
- January 29, 2013
- Date of Event
- December 24, 2012
- Report Date
- January 21, 2013
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- Report Source
- User Facility report
- Reporter Location
- MN, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
RT (RESPIRATORY THERAPY) CALLED TO SPECIAL CARE NURSERY TO TAKE A LOOK AT SIPAP. SIPAP ACTING "FUNNY." BIPHASIC MODE UNIT WOULDN'T HOLD PRESSURE AND SEEMED LIKE IT WASN'T GIVING BREATHS. THE VENT WAS IN USE FOR 40 HOURS WHEN THE EVENT OCCURRED. THE PATIENT EXPERIENCED INCREASED WORK OF BREATHING AND DECREASED OXYGEN SATURATION. THE DEVICE WAS IN PLACE ON A FULL-TERM INFANT. CHANGED OUT TO ANOTHER SIPAP UNIT IN SAME MODE AND SETTINGS AND ALL WORKED GOOD. RT REQUESTED THAT BIOMED SEND THE LOW FLOW SIPAP OUT TO CAREFUSION FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38437 | VIASYS | VENTILATOR, CONTINUOUS | CBK | CAREFUSION | 675-CFG-005 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 DAY |