FDA Adverse Event
Death
Summary report: N
CAREFUSION
MDR report key: 5955552
·
Received September 15, 2016
Report
- Report Number
- MW5064783
- Event Type
- Death
- Date Received
- September 15, 2016
- Date of Event
- April 8, 2016
- Report Date
- September 1, 2016
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT AWOKE FROM NAP ON LTV 1150 VENTILATOR, HAD CARDIORESPIRATORY ARREST (REASON UNK, WITNESSED BY NURSE, CPR INITIATED, 911 CALLED). EMS TRANSPORTED PT TO EMERGENCY DEPARTMENT. PT EXPIRED A FEW HOURS LATER. EQUIPMENT WAS PICKED UP, TESTED BY INDEPENDENT BIO MEDICAL TECHNICIANS. EQUIPMENT WAS THEN FORWARDED TO MANUFACTURER FOR ADD'L TESTING AND DOWNLOAD OF DATA. ALL TESTING CAME BACK NEGATIVE FOR FAILURE OR ERRORS. POST MORTEM RESULTS REQUESTED BUT NOT OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603482 | CAREFUSION | LTV VENTILATOR | CBK | CAREFUSION | 1150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 YR | Death |