FDA Adverse Event
Malfunction
Summary report: N
840
MDR report key: 1847473
·
Received September 24, 2010
Report
- Report Number
- 1847473
- Event Type
- Malfunction
- Date Received
- September 24, 2010
- Date of Event
- September 17, 2010
- Report Date
- September 24, 2010
- Manufacturer
- COVIDIEN PURITAN BENNETT
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
VENTILATOR FAILED WHILE ON PATIENT. VENTILATOR STOPPED AND ALARMED, DISPLAY INDICATED "VENT INOP." RESPIRATORY THERAPIST (RT) WAS NEARBY AND CAME TO PATIENT ROOM. NURSE BAGGED PATIENT. VENTILATOR REPLACED WITH WORKING DEVICE.====================== MANUFACTURER RESPONSE======================MANUFACTURER IS SENDING SERVICE ENGINEER TO REPAIR DEVICE UNDER WARRANTY
Description of Event or Problem · 1
VENTILATOR FAILED WHILE ON PATIENT. VENTILATOR STOPPED AND ALARMED, DISPLAY INDICATED "VENT INOP." RESPIRATORY THERAPIST (RT) WAS NEARBY AND CAME TO PATIENT ROOM. NURSE BAGGED PATIENT. VENTILATOR REPLACED WITH WORKING DEVICE.====================== MANUFACTURER RESPONSE======================MANUFACTURER IS SENDING SERVICE ENGINEER TO REPAIR DEVICE UNDER WARRANTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 840 | VENTILATOR, CONTINUOUS | CBK | COVIDIEN PURITAN BENNETT | 840 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |