MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240

Device Problem No Audible Alarm (1019)

Patient Problem Arrhythmia (1721)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

Reporting institution phone # (b)(6).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.

Event Description

It was reported there was no audible alarm from the monitor for this patient who developed an arrhythmia which progressed to cardiopulmonary arrest.Resuscitation was performed successfully and the patient was recovering favorably in the hospital's inpatient ward.It remains unclear whether there was a delay in care related to the alleged lack of audible alarm.

Manufacturer Narrative

A philips field service engineer (fse) went onsite to evaluate the device in question.The fse tested the speakers and the results showed they worked to specification on both devices.The fse could not reproduce the customer's alleged malfunction.The fse indicated the mx800 bedside monitor had been connected to the patient through an x2 module and there was a delay in patient care by four minutes; however, it did not impact the patient.The patient has recovered since the time of event.Philips requested for the retrieval of logs to be reviewed by an internal philips product support engineer for further evaluation.A review of the available log file confirms there were alerts for box2 from 9:55 ¿ 12:22 on mon1 and picix.Configuration files and status logs were provided for the mx800 monitor to provide clarity regarding the audible alarms.The configuration file has information on the configuration of the respective patient monitor including alarm settings, such as alarm limits or alarm volume.However, these settings are only of limited value ¿ since these settings can also be changed in monitoring mode.Therefore they will not help us to determine what the situation was at the time of the event.Furthermore, it is not possible to determine retrospectively, if a selected alarm volume was appropriate to the environmental noise level at the time of the event.Example from the configuration file below showing that the alarm low volume in one of the monitor settings block is set to ¿2¿.The status log has information on the status of the monitor.E.G., if a monitor would perform a reboot ¿ and thus would temporarily not be able to monitor the patient, it could be seen in the section of ¿fatal errors¿.The status log for the respective patient monitor does not have any entries in this section.Except below: in order to get more information on the alarming status of the monitor, pictures of the ¿review alarms window¿ of the respective monitor (mx800) and its companion (x2 or x3) would be required as well the device report and the configuration file of the companion.However, as mentioned above, it still would not be possible to determine retrospectively, what the alarm volume settings were at the time of the event and whether these settings were appropriate for the situation and the environmental noise level.Based on the information available and the logs provided by the customer, the customer's allegation could not be confirmed.The philips fse could not reproduce the alleged malfunction as the speakers worked to specification.The audit logs showed alerts for box2 from 9:55 ¿ 12:22 on mon1 and picix and the configuration files provided showed that alarms were selected.However, they could not help us determine what the situation was at the time of the event nor can they help us discern if a selected alarm volume was appropriate to the environmental noise level at the time of the event.Based on the information provided in the case, the logs files, and by the philips fse and pse, the customer's alleged malfunction could not be confirmed nor could they be reproduced.The speakers on both units worked to specification as tested by the philips fse.The logs files provided demonstrate alarms were selected; however, they do not tell us if a selected alarm volume was appropriate to the environmental noise level at the time of the event.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 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: 18984892
• MDR Text Key: 338659718
• Report Number: 9610816-2024-00172
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K150310
• 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?: No
• Device Operator: Health Professional
• Device Model Number: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• 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): Required Intervention