FDA Adverse Event
Death
Summary report: N
840 VENTILATOR
MDR report key: 1203023
·
Received October 17, 2008
Report
- Report Number
- 8020893-2008-00540
- Event Type
- Death
- Date Received
- October 17, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 8, 2008
- Manufacturer
- PURITAN-BENNETT CORP.
- Product Code
- CBK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESPIRATORY THERAPIST STATED HE DOES NOT BELIEVE THE VENTILATOR WAS THE CAUSE OF THE INCIDENT. THE PT WAS FAIRLY SICK AT THE TIME, AND JUST CAME OUT OF SURGERY AND WAS PLACED ON THE VENTILATOR, THE MEDICAL STAFF WAS PRESENT AT THE TIME OF THE INCIDENT AND NOTICED THE VOLUME WAS LOW AND THE PEAK WAS HIGH. THE STAFF DID MANUAL RESUSCITATION. THE PT SUBSEQUENTLY DIED. THE DEVICE WAS TESTED, AND PASSED ACCORDING TO NPB'S SPECS, ERROR LOGS HAVE ALSO BEEN REVIEWED, AND THERE IS NO INDICATION OF VENTILATOR MALFUNCTION.
Description of Event or Problem · 1
NELLCOR PURITAN BENNETT RECEIVED INFO STATING AFTER SURGERY A PT WAS HURT ON AN 840 VENTILATOR.
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 |