MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 2.4GHZ

Model Number 865351

Device Problem Defective Alarm (1014)

Patient Problem Bradycardia (1751)

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

The engineer confirmed that alarms were provided (at the pic ix) for bed/device label h1-1 / mx40-8 during the reported incident timeframe of 07:40 on (b)(6) 2023.Physiological alarms for pause, xbrady, and asystole conditions were provided.The tele weak signal given at 07:46:01 technical inop did not result in loss of connection/association between the mx40 and pic ix.The audit log also shows a loss of connection/association between.The mx40 and pic ix at 10:13:12 (more than 2 hours after the incident timeframe).¿tele: service battery¿ technical inop indicates the battery has exceeded the maximum charge cycle limit and reached the end of its useful life.It is a message to the user to replace the battery.The battery will still power the mx40, but performance can be impacted.Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the central had not given alarm.The device was in use in telemetry mode.

Manufacturer Narrative

A philips response service engineer (rse) spoke with the customer and reviewed the audit logs.The patient was wearing the mx40 monitor during the incident on bed label h1-1.The customer was informed that according the log files, the central has alarmed as expected.Furthermore the rse stated "we had conversation with our clinical application specialist (cas), checked the curves provided by customer and once more checked the log files too.We couldn¿t find any problems regarding the function of our equipment and reported this to customer accordingly." a good faith effort (gfe) conducted confirmed that the customer was expecting a brady and asystole alarm, and alleged these alarms were not generated by the central.According to customer ¿device didn¿t alarm immediately but instead a moment later.The patient was in telemetry due to bradycardia so everyone was aware of patient¿s condition¿ the tele weak signal given at 07:46:01 technical inop did not result in loss of connection/association between the mx40 and pic ix.The audit log also shows a loss of connection/association between the mx40 and pic ix at 10:13:12 (more than 2 hours after the incident timeframe).The ¿tele: service battery¿ technical inop indicates the battery has exceeded the maximum charge cycle limit and reached the end of its useful life.It is a message to the user to replace the battery.The battery will still power the mx40, but performance can be impacted.The rfda log shows a loss of association between the mx40 and pic ix followed by re association at 20:01:31 on (b)(6), 2023.During a battery change.There were no losses of connection/association between the mx40 and pic ix during the reported incident timeframe.It also shows a loss of association between the mx40 and pic ix followed by re association at 10:13:12 on (b)(6), 2023 due to a weak signal, and a loss of association between the mx40 and pic ix when the mx40 was put into standby mode at 10:37:01.The device debug log shows an mx40 reboot event at 20:02:25 on (b)(6), 2023.When the battery was changed; a loss of connection/association with the pic ix at 10:13:27 related to poor signal strength and that the mx40 was put into standby mode at 10:37:01 on (b)(6), 2023.Note: based on battery voltages captured in the log (reboot events), it can be determined the customer is using the philips rechargeable li-ion battery.Patient wearing monitor (pwm) log review can further confirm battery change/reboot events.Analysis results indicate that the mx40 performs the measurement analysis, generates the alarms and sends them to the pic ix.It was confirmed that the mx40 was connected to the pic ix and providing physiological alarms during the reported incident timeframe.In addition, the pse stated "i confirm that alarms were provided (at the pic ix) for bed/device label h1-1 / mx40-8 during the reported incident timeframe of 07:40 on (b)(6) 2023.Physiological alarms for pause, xbrady, and asystole conditions were provided." based on the information available and the testing conducted, the cause of the reported problem was the user lack of alarm awareness.The reported problem was not confirmed.The engineers provided their analysis findings.The device was confirmed to be operating per specifications and no alarm failure was identified.Philips mx40 patient wearable monitor has not caused or contributed to the event.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX40 2.4GHZ
• Type of Device: INTELLIVUE MX40 2.4GHZ
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17940810
• MDR Text Key: 326540174
• Report Number: 1218950-2023-00767
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2016
• 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