INTELLIVUE MX550 PATIENT MONITOR
Report
- Report Number
- 9610816-2025-000511
- Event Type
- Malfunction
- Date Received
- June 25, 2025
- Date of Event
- May 29, 2025
- Report Date
- June 30, 2025
- Manufacturer
- PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
- Product Code
- MHX
- UDI-DI
- 00884838038783
- PMA / PMN Number
- K131872
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER WHO WISHED TO HAVE THE ECG READ CORRECTLY. THEY EXPLAINED THE ECG WAVE WAS THERE, BUT THE STAFF REPORTED THE MONITOR DID NOT RECOGNIZE THE VT RHYTHM AND EXPECTED ALARMS. THEY ALSO STATED THE RHYTHM STRIP DID NOT CLASSIFY THE VENTRICULAR BEATS AS "V" BUT AS "N" FOR NORMAL. THE FOLLOWING LOG REVIEW WAS PERFORMED: THE CSE DOWNLOADED THE PHYSIO DATA FROM THE CENTRAL STATION REGARDING THE BED IN QUESTION (ESICU 05) BETWEEN 0313 AND 0318. THE CLINICAL AUDIT TRAIL SHOWED THE ALARM NOTED, IN THE STRIPS SENT BY THE CUSTOMER, WAS DETECTED AS A V-TACH ALARM. THE ALARM WAS PAUSED DURING THAT TIME AND WAS ONLY ANNOUNCED AS AN UNACKNOWLEDGED ALARM AFTER THE TWO-MINUTE PAUSE HAD TIME-OUT. THE INTERNAL PSE REVIEWED THE CENTRAL STATION LOGS AND POINTED OUT THE CUSTOMER ALSO HAS THE ALARMS PAUSED DURING THE TIME OF THE STRIP SHOWING V TACH AND NO ALARM. (B)(6) 2025 03:14:03 MY INSTITUTION CSIC05SP VENT FIB/TACH GENERATED AT 03:13:56. PIC IX: CSICU1 RED ALARM (B)(6) 2025 03:14:02 MY INSTITUTION CSIC05SP RESUME ALL ALARMS MX8-CS5 RESUME ALL ALARMS (B)(6) 2025 03:14:00 MY INSTITUTION CSIC05SP PAP NO PULSE GENERATED AT 03:13:53. PIC IX: CSICU1 LOGGED INOP (B)(6) 2025 03:12:56 MY INSTITUTION CSIC05SP !!DLYS BAG FULL ENDED. PIC IX: CSICU1 YELLOW INOP (B)(6) 2025 03:12:00 MY INSTITUTION CSIC05SP ARTM 299 >295 ENDED. PIC IX: CSICU1 YELLOW ALARM (B)(6) 2025 03:12:00 MY INSTITUTION CSIC05SP AFIB ENDED. PIC IX: CSICU1 YELLOW ALARM (B)(6) 2025 03:11:59 MY INSTITUTION CSIC05SP PAUSE ALL ALARMS MX8-CS5 PAUSE ALL ALARMS WHEN THE ALARMS WERE RESUMED, THEY GOT THE VENT FIB/TACH ALARM. EVEN THOUGH THE MONITOR LEARNED THE WIDE COMPLEX AS "N" (NORMAL), THE RATE WAS HIGH ENOUGH AND THERE WERE SUFFICIENT "V" (VENTRICULAR) BEATS TO CAUSE AN ALARM. THE CSE REFERRED TO THE SNIPPET ATTACHMENT FROM THE CLINICAL AUDIT TRAIL, WHICH SHOWED ALARMS WERE PAUSED DURING THE V-TACH ALARM WHICH OCCURRED. THE ALARM WAS THEN ANNOUNCED ONCE THE PAUSE ALARMS ENDED AT 3:14:02. THE ALARMS WERE THEN PAUSED AGAIN 21 SECONDS LATER. THE CSE MENTIONED IT WAS CLEAR THAT THE PATIENT HAD NUMEROUS ALARMS AND THAT THE STAFF HAD PAUSED ALARMS FREQUENTLY FOR THIS PATIENT. JUST IN THIS SMALL EXTRACT FROM THE CLINICAL AUDIT TRAIL, THE ALARMS WERE PAUSED FOUR TIMES. THE CSE SUGGESTED IT MAY BE NECESSARY TO INFORM THE STAFF OF THE DIFFERENCE BETWEEN ACKNOWLEDGE AND PAUSE FUNCTIONS. ACKNOWLEDGING ALARMS ALLOWS FOR ALARMS TO BE HEARD WHEN ESCALATED OR FOR NEW RED ALARMS TO BE ANNOUNCED INCLUDING V-TACH ALARMS WHICH WOULD OCCUR DURING THE TIMEOUT PERIOD. PAUSING ALARMS, PAUSES ALL ALARMS FOR TWO MINUTES, UNCONDITIONALLY AND NO ALARMS WILL BE HEARD DURING THOSE TWO MINUTES REGARDLESS OF THEIR PRIORITY. THE LOGS WERE SENT TO AN INTERNAL PHILIPS PRODUCT SUPPORT ENGINEER (PSE) FOR FURTHER ANALYSIS. A REVIEW OF THE RHYTHM STRIPS PROVIDED INDICATE THE STAR ALGORITHM CLASSIFIED THE BEATS AS N, WHICH IS WHY A VTACH ALARM WAS NOT GENERATED. THE RAW ECG DATA WAS OBTAINED BY R&D. UNFORTUNATELY, THE DATA OBTAINED WAS NOT DURING THE INCIDENT TIME AND SHOWS A PACED RHYTHM. IT IS LIKELY IF A RELEARN OCCURRED WHILE THE PATIENT WAS HAVING THIS RHYTHM AND THE ALGORITHM LEARNED IT AS A NORMAL RHYTHM. THE GOAL OF LEARNING IS TO LEARN THE PATIENT¿S NORMAL COMPLEXES AND/OR PACED COMPLEXES. THE LEARNING PROCESS INVOLVES THE FIRST 15 VALID OR NON-NOISY BEATS ENCOUNTERED DURING THE LEARNING PHASE. THE MOST FREQUENTLY SEEN, NARROWEST, AND ON-TIME BEATS ARE SELECTED TO REPRESENT THE BEAT LABELED AS NORMAL. FOR THIS REASON, LEARNING SHOULD BE INITIATED DURING PERIODS WHEN THE PATIENT¿S RHYTHM IS PREDOMINANTLY NORMAL, AND THE ECG SIGNAL IS RELATIVELY NOISE FREE. IF THE LEARNING PHASE TAKES PLACE DURING A VENTRICULAR RHYTHM, THE ECTOPIC BEATS CAN BE INCORRECTLY LEARNED AS THE NORMAL QRS COMPLEX, RESULTING IN MISSED DETECTION OF EVENTS. ONCE THE ALGORITHM DETECTS AND MEASURES THE QRS, THE BEAT IS LABELED AS N (NORMAL), S (SUPRAVENTRICULAR), V (VENTRICULAR ECTOPIC), OR P (PACED). TO AID THE ALGORITHM IN LABELING A NEW BEAT, PREVIOUSLY DETECTED BEATS THAT HAVE SIMILAR SHAPES ARE GROUPED INTO TEMPLATE FAMILIES. EACH PATIENT CAN HAVE UP TO 16 DIFFERENT ACTIVE TEMPLATE FAMILIES FOR EACH INDIVIDUAL LEAD. TO KEEP THE TEMPLATE FAMILY INFORMATION CURRENT, THEY ARE DYNAMICALLY CREATED AND REPLACED AS THE PATIENT¿S BEAT MORPHOLOGY CHANGES. IF A PATIENT BEGINS TO DISPLAY A NEW BEAT MORPHOLOGY, A NEW TEMPLATE FAMILY IS CREATED. OLDER TEMPLATE FAMILIES FROM BEATS NO LONGER EXPERIENCING ARE AUTOMATICALLY DELETED. THE IFU HAS THE FOLLOWING WARNING: "LEAD FALLBACK TRIGGERS AN AUTOMATIC ARRHYTHMIA RELEARN." WARNING IF ARRHYTHMIA LEARNING TAKES PLACE DURING VENTRICULAR RHYTHM, THE ECTOPICS MAY BE INCORRECTLY LEARNED AS THE NORMAL QRS COMPLEX. THIS MAY RESULT IN MISSED DETECTION OF SUBSEQUENT EVENTS OF V-TACH AND V-FIB. FOR THIS REASON YOU SHOULD: ¿ TAKE CARE TO INITIATE ARRHYTHMIA RELEARNING ONLY DURING PERIODS OF PREDOMINANTLY NORMAL RHYTHM AND WHEN THE ECG SIGNAL IS RELATIVELY NOISE-FREE ¿ BE AWARE THAT ARRHYTHMIA RELEARNING CAN HAPPEN AUTOMATICALLY ¿ RESPOND TO ANY INOP MESSAGES (FOR EXAMPLE, IF YOU ARE PROMPTED TO RECONNECT ELECTRODES) AS THE EFFECTIVENESS OF THE ARRHYTHMIA MONITORING FOR THE PATIENT IS COMPROMISED. ¿ BE AWARE THAT A DISCONNECTED EASI ELECTRODE TRIGGERS AN ARRHYTHMIA RELEARN ON ALL LEADS ¿ ALWAYS ENSURE THAT THE ARRHYTHMIA ALGORITHM IS LABELING BEATS CORRECTLY." ARRHYTHMIA RELEARNING IS INITIATED AUTOMATICALLY WHENEVER ECG MONITOR IS SWITCHED ON, PACED MODE IS CHANGED, PATIENT CATEGORY IS CHANGED, ECG SOURCE IS CHANGED, OR A LEADS OFF INOPERATIVE CONDITION LAST GREATER THAN 60 SECONDS. BASED ON THE INFORMATION AVAILABLE IN THE CASE AND THE LOGS PROVIDED BY THE CUSTOMER, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED TO BE A USER ERROR. THE ALARMS WERE PAUSED; THEREFORE, NO ALARM COULD BE HEARD. THE REPORTED PROBLEM WAS CONFIRMED. THE UNIT WORKED AS DESIGNED AND CONFIGURED. THE AUDIT LOGS PROVIDED SHOWED THE ALARMS WERE PAUSED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.
B5: CORRECTION.
IT WAS REPORTED THE STAFF HAD A PATIENT ON (B)(6) 2025 THAT WHILE ON DIALYSIS EXHIBITED A VTACH RHYTHM, BUT THE MONITOR DID NOT ALARM. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT; THERE WAS NO ADVERSE EVENT REPORTED.
IT WAS REPORTED THE STAFF HAD A PATIENT ON (B)(6) 2025 THAT WHILE ON DIALYSIS EXHIBITED A VTACH RHYTHM, BUT THE MONITOR DID NOT ALARM. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT; THERE WAS NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1142757 | INTELLIVUE MX550 PATIENT MONITOR | INTELLIVUE MX550 PATIENT MONITOR | MHX | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | INTELLIVUE PATIENT MONITOR MX550 | 00884838038783 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |