FDA Adverse Event Malfunction Summary report: N

DRAEGER, INC.

MDR report key: 8623213 · Received May 20, 2019

Report

Report Number
8623213
Event Type
Malfunction
Date Received
May 20, 2019
Date of Event
April 1, 2019
Report Date
May 3, 2019
Manufacturer
DRAEGER MEDICAL SYSTEMS, INC.
Product Code
CBK
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

PATIENT WAS ADMITTED TO THE NEUROLOGICAL-ICU BEGAN A SYNCHRONIZED INTERMITTENT MECHANICAL VENTILATION PROTOCOL ON A DRAEGER V500 VENTILATOR. THE PATIENT'S VENTILATOR SETTINGS AT THIS TIME WERE AS FOLLOWS: RATE: 12, O2%: 40, SENS: 5, VT: 450, PEEP: 6, PS: 5. THE VENTILATOR GENERATED LEAKAGE, HIGH RESPIRATORY RATE, FLOW MEASUREMENT INACCURACIES, LOW/HIGH AIRWAY PRESSURE, AND LOW/HIGH MV ALARMS. THE VENTILATOR ALSO GENERATED A "MACHINE GUNNING" VIBRATIONAL NOISE. THE RESPIRATORY THERAPIST WAS REQUIRED TO REMOVE THE PATIENT FROM THE V500 VENTILATOR AND PROVIDE MANUAL RESPIRATION IN ORDER TO REPLACE THE FLOW SENSOR AND THE EXPIRATORY FILTER. THE VENTILATOR CONTINUED TO COMPENSATE FOR THE LEAKAGE BY INCREASING THE RATE AND THE PRESSURE. THE VENTILATOR CONTINUED TO GENERATE THE SAME ALARMS AND VIBRATIONAL NOISE. THE RESPIRATORY THERAPIST SEQUESTERED THE VENTILATOR BEFORE ANY PATIENT HARM COULD BE DONE AND GAVE IT TO BIOMEDICAL ENGINEERING FOR TROUBLESHOOTING. CONCLUSION: THE ALARMS AND VIBRATIONAL NOISE ARE CAUSED BY LEAKAGE ASSOCIATED WITH THE DISPOSABLE EXHALATION VALVE (DIAPHRAGM, SEAL OF THE DIAPHRAGM, PRESSURE SENSOR PORT, FLOW SENSOR PORT, MATERIAL DESIGN). THESE ISSUES HAVE NOT BEEN SHOWN WITH REPROCESSED NON-DISPOSABLE EXHALATION VALVES. MANUFACTURER RESPONSE FOR VENTILATORS, INTENSIVE CARE, DRAEGER, INC. (PER SITE REPORTER). THE ALARMS AND INACCURATE READINGS ARE CAUSED BY ISSUES RELATED TO THE FLOW SENSOR (ATTACHED TO THE DISPOSABLE EXHALATION VALVE).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
416872 DRAEGER, INC. DISPOSABLE EXPIRATORY VALVE CBK DRAEGER MEDICAL SYSTEMS, INC. EVITA INFINITY V500

Patients

Seq Age Sex Outcome Treatment
1