MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX550 PATIENT MONITOR

Model Number 866066

Device Problem Defective Alarm (1014)

Patient Problems Bradycardia (1751); Asystole (4442)

Event Date 02/24/2024

Event Type  Death  

Manufacturer Narrative

The philips engineer reviewed the ecg trace, revealing the patient's pacemaker continued to generate stimulation peaks and simulated beats at the time the monitor measured a heart rate of 70 bpm; therefore, no ecg alarm was generated.Desaturation and pulse alarms were occurring at this time as well.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.(b)(6).

Event Description

It was reported the intensive care unit (icu) patient was found deceased but no ecg alarms for bradycardia or asystole were generated at the monitor or central station.When the biomed reviewed the logs, it was determined there were no ecg alarms during the event, with the heart rate being around 70bpm wit pvcs.It was also indicated only desaturation alarms of <65% were noted.

Manufacturer Narrative

A clinical product specialist reviewed the clinical audit log and the rhythm strip provided.On february 24, 2024, at 08:44:04, the spo2 low limit was changed to 83 at the bedside monitor.At 08:44:08, the desat limit was changed to 80 at the bedside monitor.At 08:44:10, the spo2 low limit was changed to 80 at the bedside monitor.Between 09:15 to 09:33, there are several desat alarms logged.The alarms were acknowledged at the bedside monitor.At 09:33:38, the desat limit was changed to 70, and the spo2 low limit was changed to 70.At 09:34:12, the respiratory and nbp alarms were switched off.When individual alarms are switched off, the ¿alarms off¿ symbol is shown beside the measurement numeric at the bedside and at the pic ix.No red or yellow physiological alarms are sounded, and no messages are shown.However, inop messages are shown, but the inop tones are not sounded.At 9:45:30, the desat limit was changed to 65.At 12:15:16, a desat alarm generated and ended at 12:42:30.Starting at 12:39, there are multiple ¿spo2 no pulse¿ inops.The alarms were acknowledged at the bedside at 12:43:51 and 12:49:58.At 12:50:31, the spo2 alarms were switched off.The monitor was put into standby at 12:50:55.A review of the rhythm provided at 12:50:46 shows a ventricular paced rhythm.There is a question mark for the spo2 and pulse numeric due to the ¿spo2 no pulse¿ inop logged in the audit log.The heart has two components: electrical and mechanical.The star algorithm processes the patient¿s electrical ecg signal to identify and classify the patient¿s beats, and then generate alarms.The electrical signal is displayed by the ecg waveform and the hr value.The star algorithm does not process the mechanical contraction of the heart which is displayed by the pulse value (from the spo2 or invasive pressure measurement) on the monitor.There is a clinical condition called pulseless electrical activity (pea).When the patient is in pea, the heart¿s electrical system continues to work but may be too week to stimulate the heart to contract, leading to cardiac arrest.The star algorithm is a tool to assist the clinician in managing and evaluating their patients.The rhythm strips provided continue to show the heart¿s electrical system responding to the pacer pulse resulting in no ecg alarms.Philips does not have an alarm for pea, because the star algorithm continues to recognize and classify the rhythm and display the hr value.The first alarm that you would get on the monitor in this condition is the ¿spo2 no pulse¿ inop.In conclusion, the patient's pacemaker continued to stimulate the heart at 70 bpm and the spo2 measurement displayed a question mark and a no pulse inop.This indicated the patient was in pea.The heart continued to respond to the paced pacemaker impulse, resulting in no ecg alarms.Philips does not have an alarm for pea and the device functioned as specified.Based on this information, the device did not cause or contribute to the reported event and functioned as designed.In addition, caregivers were changing alarm limits for desaturation over time, which suggests they were aware of the patient's deteriorating condition.Based on the information available, the device performed according to specification, and the criteria for ecg alarm generation was not met.The device remains in use at the customer site.

• Brand Name: INTELLIVUE MX550 PATIENT MONITOR
• Type of Device: INTELLIVUE MX550 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18967405
• MDR Text Key: 338439094
• Report Number: 9610816-2024-00164
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: 00884838038783
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866066
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death