FDA Adverse Event Summary report: N

SERVO-I

MDR report key: 1883989 · Received October 14, 2010

Report

Report Number
1883989
Date Received
October 14, 2010
Date of Event
October 4, 2010
Report Date
October 14, 2010
Manufacturer
MAQUET
Product Code
CBK
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

EXCESSIVE "RAINOUT" IN THE EXHALATION SIDE OF THE VENTILATOR'S PATIENT CIRCUIT IS CAUSING THE VENTILATOR'S EXHALATION CASSETTE TO FAIL. THE VENTILATOR WILL EITHER GENERATE AN ERROR MESSAGE DURING USE, OR A WET CASSETTE WILL NOT PASS A PRE-USE TEST BEFORE TREATMENT IS STARTED.THIS IS NOT A ONE-TIME EVENT, BUT A PROBLEM THAT HAS BEEN GOING ON FOR SEVERAL MONTHS. THE MANUFACTURER OF BOTH THE VENTILATOR AND THE HUMDIFIER WERE CONTACTED.THE EXHALED GAS FROM THE PATIENT IS PASSED FROM THE PATIENT BY WAY OF THE BREATHING CIRCUIT INTO THE EXHALATION SIDE OF THE CIRCUIT. THIS GAS IS HEATED USING A HEATED WIRE. THE INTENT IS TO REDUCE THE AMOUNT OF RAINOUT IN THE CIRCUIT. BUT THIS HEATED GAS IS PASSED INTO THE EXHALATION CASSETTE OF THE VENTILATOR BEFORE IT LEAVES THE VENT. THE MOISTURE IS CREATING A PROBLEM WITH THIS CASSETTE. FILTERS HAVE BEEN ADDED TO THE PATIENT CIRCUIT TO HELP, BUT THE RESPIRATORY THERAPISTS (RT) ARE STILL HAVING TO CLEAR THE CIRCUIT OF WATER EVERY 4 HOURS TO AVOID VENTILATOR FAILURE. RT HAS IMPLEMENTED A DRYING PROCESS FOR THE CASSETTES. THIS HAS IMPACTED THE PROBLEM OF PRE-USE TEST FAILURES, BUT HAS DONE NOTHING ABOUT THE EXCESSIVE MOISTURE AFTER 4 HOURS OF USE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DR. BELIEVES EXCESSIVE INTERRUPTION OF VENTILATION IS DETRIMENTAL TO THE PATIENT.====================== MANUFACTURER RESPONSE FOR VENTILATOR, CRITICAL CARE, SERVO-I======================THEY HAVE BEEN OUT TO OUR HOSPITAL BEFORE TO MEET WITH OUR RT MANAGER. THEY RECOMMENDED THE IMPLEMENTATION OF A DRYING PROCEDURE FOR THE CASSETTES AFTER THE VENTILATOR COMES OFF THE PATIENT OR FAILS. THIS WAS DONE, BUT THE VENTILATOR STILL FAILS AT AN UNACCEPTABLE RATE. THEY RECEIVED A COPY I SENT TO THE RT MANAGER REPORTING WHAT I HAVE FOUND AFTER BENCH TESTING. THAT LETTER WAS FORWARDED TO MAQUET LAST WEEK. THEY WANT TO MEET, BUT HAVE NOT OFFERED ANY OTHER ANSWERS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET 06487800 N/A

Patients

Seq Age Sex Outcome Treatment
1 *