FDA Adverse Event
Death
Summary report: N
840 VENTILATOR
MDR report key: 1644698
·
Received March 26, 2010
Report
- Report Number
- 8020893-2010-00149
- Event Type
- Death
- Date Received
- March 26, 2010
- Date of Event
- February 25, 2010
- Report Date
- February 25, 2010
- Manufacturer
- PURITAN BENNETT CORP.
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN, HAS BEEN IN CONTACT WITH HOSPITAL. A FOLLOW UP MDR WILL BE SENT TO THE FDA SHOULD FURTHER INFORMATION BECOME AVAILABLE.
Description of Event or Problem · 1
RECEIVED INFORMATION STATING THAT A HOSPITAL NURSE HEARD AN ALARM, WALKED INTO THE PT'S ROOM AND FOUND THAT THE VENTILATOR'S POWER SWITCH WAS IN THE OFF POSITION. A COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE DEVICE. THERE WAS NO INDICATION OF THE DEVICE MALFUNCTION AND THE DEVICE PASSED ALL PERFORMANCE VERIFICATION AND EXTENDED SELF TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 840 VENTILATOR | VENTILATOR | CBK | PURITAN BENNETT CORP. | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |