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