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

Model Number 865240

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  Death  

Event Description

It was reported to philips the patient passed away and the customer requested assistance in determining if the monitor was operating correctly.

Manufacturer Narrative

Logs were reviewed and analyzed by a philips field service engineer (fse) and it was determined that the philips equipment was functioning as expected.The clinical logs from (b)(6) 2024 looks like the patient sustained some pvcs around 08:42 which last until around 08:45.Beginning at 08:46 the system alert for a leads off and seconds later red alarm for ecg leads off.Alarm was acknowledging at the ss station at 08:47.Because the alarm was acknowledged but not address a reminder alarm went off again 3min later at 08:50 and every 3min after until 09:06 when someone intervened with the monitor.Based on the clinical log information the monitors worked as expected and responded to the patient based on the events that was happening.Today (b)(6) 2024 the system was tested using a patient simulator which is used to generate patient rhythms and during this testing the system responded and log each alarm that was sent from the patient simulator to the bedside monitor and central station.In conclusion i have not found any problems related to the patient monitor devices in question and have concluded that the monitors are safe to use.Next steps going forward will be to get our clinical specialists on a conference call with the nurse coordinator so they can get a better understanding of the alarm setup that they currently have in the icu.A clinical harm review re-assessment was performed by the pms clinical expert: - the reported event of patient death was reviewed by the pms clinical expert.This event is assessed as not related to the device in this case.Based on the clinical audit log information reviewed by engineering, the monitors worked as expected and the users responded to the patient based on the logs.The system was also tested using a patient simulator which was used to generate patient rhythms, revealing the system responded and logged each alarm.The clinical specialist will also meet with the nurse coordinator customer to review the alarm configuration in the icu.Based on this information, the system was performing as intended and there was no allegation the system was related to the reported death.This testing also satisfied the customer's request to verify functionality.If additional information is obtained, please send it to the pms clinical expert for further review.Otherwise, no further action is required.Based on the information provided in the case and the result of the log evaluation provided by the fse, the customer's allegation could not be confirmed.The device was confirmed to be operating per specifications and no failure was identified.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 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: 18831505
• MDR Text Key: 336823799
• Report Number: 9610816-2024-00120
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• 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