FDA Adverse Event
Malfunction
Summary report: N
EVITA 4
MDR report key: 1869092
·
Received September 27, 2010
Report
- Report Number
- 1869092
- Event Type
- Malfunction
- Date Received
- September 27, 2010
- Date of Event
- September 3, 2010
- Report Date
- September 27, 2010
- Manufacturer
- DRAEGER, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
PATIENT WAS RECEIVING A CHEST X-RAY, WHEN THE RN AND RESPIRATORY THERAPIST (RT) OUTSIDE THE PATIENT'S ROOM HEARD THE FAILURE ALARM FOR THE VENTILATOR. THE VENTILATOR WAS NOT CYCLING. SATURATION WAS MAINTAINED AND A BRIEF PERIOD OF ATRIAL FIBRILLATION OCCURRED (PATIENT IS CHRONIC A-FIB). RT IMMEDIATELY BEGAN TO MANUALLY VENTILATE THE PATIENT AND CONTINUED UNTIL A REPLACEMENT VENTILATOR WAS INTRODUCED.====================== MANUFACTURER RESPONSE FOR VENTILATOR, INTENSIVE CARE, DRAGER EVITA 4======================SHIP DEFECTIVE PART(S) TO MANUFACTURER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVITA 4 | VENTILATOR, CONTINUOUS | CBK | DRAEGER, INC. | 8414478 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |