FDA Adverse Event Malfunction Summary report: N

PHILIPS INTELLIVUE MX550 PATIENT MONITOR

MDR report key: 11875002 · Received May 25, 2021

Report

Report Number
11875002
Event Type
Malfunction
Date Received
May 25, 2021
Date of Event
April 15, 2021
Report Date
April 27, 2021
Manufacturer
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
Product Code
MHX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MD
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

A NEW PHILLIPS MONITORING SYSTEM WAS INSTALLED ON MULTIPLE UNITS AT OUR HOSPITAL. STAFF WERE TRAINED ON THE NEW SYSTEM BY PHILLIPS. DURING THE TRAINING, THERE WAS NO INFORMATION ON THE QRS DETECTION CAPABILITIES OF THE MONITORS OR THAT THERE WAS A SYSTEM FUNCTION THAT COULD ADJUST THE DETECTION SENSITIVITY. OVER THE NEXT SEVERAL MONTHS, STAFF ON SELECT UNITS STARTED FEELING ALARM FATIGUE AS THE MONITORS WERE OVER REPORTING PATIENTS AS BRADYCARDIC OR ASYSTOLE. VARIOUS THINGS WERE TESTED TO DETERMINE THE CAUSE OF THE ERRORS IN ALARMS. MULTIPLE ELECTRODES WERE TESTED, AND STAFF WERE RETRAINED ON LEAD PLACEMENT. HOWEVER, THE OVER REPORTING OF ALARMS PERSISTED. PHILLIPS WAS CONTACTED AND IT WAS DISCOVERED THE QRS DETECTION SETTING WAS SET TO THE HIGHEST LEVEL. HAVING THE DETECTION TOO HIGH CAN CAUSE FALSE BRADYCARDIC OR ASYSTOLE ALARMS. HAVING THE DETECTION TOO LOW COULD RESULT IN FALSE TACHYCARDIA ALARMS. THE LACK OF EDUCATION ON THE MONITOR'S QRS DETECTION SETTINGS LIMITED THE STAFF'S ABILITY TO PROGRAM THE MONITORS FOR CUSTOMIZED INDIVIDUAL PATIENT CARE. ONCE THE HOSPITAL STARTED TRAINING THE STAFF (AFTER SEVERAL MONTHS FROM INSTALLATION) ON THE MONITOR'S QRS DETECTION SETTINGS, IT WAS IDENTIFIED THAT PHILLIPS FAILED TO UPDATE THE MONITORS ON ICU AND COVID ICU WITH THE MOST CURRENTLY AVAILABLE SOFTWARE. THE LACK OF UPDATED SOFTWARE PREVENTED THE STAFF FROM ADJUSTING THE QRS DETECTION CAPABILITIES. MANUFACTURER RESPONSE FOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS), PHILIPS INTELLIVUE MX550 PATIENT MONITOR (PER SITE REPORTER) PHILLIP REPORTED THE ICU AND COVID ICU UNIT ARE RUNNING OUTDATED SOFTWARE. THE SOFTWARE DOES NOT ALLOW FOR NURSING TO ADJUST QRS DETECTION ON THE MONITORS. PHILLIPS REPORTED THE MONITORS CAN STILL BE USED AND THAT THE QRS DETECTION IS AT THE LOWEST LEVEL BY DEFAULT. PHILLIPS HAS NOT YET PROVIDED AND ETA FOR THE SOFTWARE UPGRADE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
775488 PHILIPS INTELLIVUE MX550 PATIENT MONITOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866066

Patients

Seq Age Sex Outcome Treatment
1