FDA Adverse Event
Death
Summary report: N
CAREFUSION
MDR report key: 4254696
·
Received November 7, 2014
Report
- Report Number
- 2021710-2014-00066
- Event Type
- Death
- Date Received
- November 7, 2014
- Date of Event
- September 29, 2014
- Report Date
- October 9, 2014
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- PMA / PMN Number
- K073069
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
THE CAREFUSION TECHNICAL SUPPORT SPECIALIST IN (B)(4) PERFORMED AN OPERATIONAL VERIFICATION TEST ON THE VENTILATOR AND DETERMINED THAT IT PASSED ALL TESTING. THE DISTRIBUTOR ENGINEERS ALONG WITH CAREFUSION TECHNICAL SUPPORT REQUESTED FURTHER EVENT INFO FROM THE HOSP; HOWEVER, THE (B)(6) DIRECTOR AT THE HOSP DECIDED TO 'CANCEL THE COMPLAINT' BECAUSE THE 'EVIDENCE IS UNCLEAR.'
Description of Event or Problem · 1
CAREFUSION TECHNICAL SUPPORT IN (B)(4) REPORTED AN INCIDENT WITH THE VENTILATOR WHILE IN PT USE. THE VENTILATOR WAS REPORTED TO HAVE "STOPPED AIR SUPPLY" AND THE PT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718632 | CAREFUSION | CBK | CAREFUSION | AVEA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |