FDA Adverse Event
Death
Summary report: N
840 VENTILATOR
MDR report key: 1053117
·
Received May 28, 2008
Report
- Report Number
- 8020893-2008-00247
- Event Type
- Death
- Date Received
- May 28, 2008
- Date of Event
- March 23, 2008
- Report Date
- April 29, 2008
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- CBK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NURSE ATTENDING THE PT REPORTED, THAT SHE CHECKED VENTILATOR'S CONNECTIONS AND PLACED THE PT ON HIS BACK. PT WAS REPORTED TO BE DUSKY THEN MANUALLY VENTILATED THE PT. PT CODED AND SUBSEQUENTLY EXPIRED. THE DEVICE WAS TESTED AND PASSED ACCORDING TO NPB'S SPECS, ERROR LOGS HAVE BEEN ALSO REVIEWED, AND THERE IS NO INDICATION OF VENTILATOR MALFUNCTION.
Description of Event or Problem · 1
NELLCOR PURITAN BENNETT RECEIVED INFO STATING THAT WHILE PERFORMING HYGIENE ON A PT (WHO WAS TURNED SIDEWAYS) THE VENTILATOR STARTED ALARMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 840 VENTILATOR | VENTILATOR | CBK | NELLCOR PURITAN BENNETT | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |