FDA Adverse Event Death Summary report: N

INSPIRATION LS VENTILATOR SYSTEM

MDR report key: 3565112 · Received January 6, 2014

Report

Report Number
3006135941-2014-00001
Event Type
Death
Date Received
January 6, 2014
Report Date
January 3, 2014
Manufacturer
EVENT MEDICAL LTD.
Product Code
CBK
PMA / PMN Number
K072590
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PK
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

HOSPITAL IN (B)(6) INDICATES VENTILATOR SHUTDOWN WHILE ON A PT. THE PT EXPIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
7297 INSPIRATION LS VENTILATOR SYSTEM VENTILATOR CBK EVENT MEDICAL LTD. LS NA

Patients

Seq Age Sex Outcome Treatment
1 Death