MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MULTI MEASUREMENT SERVER X2; PATIENT MONITOR

Model Number M3002A

Device Problems Loss of Power (1475); Output Problem (3005)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 03/01/2017

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that a patient was connected to one of our x2¿s whilst in dialysis.During that time, the patient¿s x2 went offline, and the patient coded.The patient died.

Manufacturer Narrative

According to the staff, the patient was officially pronounced at around 14:40 on (b)(6).The field service engineer (fse) looked into the audit logs from the central station and found that during the time frame 13:56:12 ¿ 15:15:29, the device was offline.It was also noticed that the patient went through multiple desat alarms.These alarms were starting from 13:20:36 ¿ 13:56:12 (4 times in total).Each of these alarms was silenced.The fse also tested the x2 in question for connectivity, as well as alarms, and all alarms were announced as intended.The device was found to be working properly.The same audit logs were sent to the piic research and development (r&d) experts and it was confirmed that the piic ix broke association with the x2 as it stopped sending messages between 13:56:12 ¿ 15:15:29.Given that the user silenced an alarm at 13:55:56, the bedside stopped sending data to the central station at 13:56:11, and the bedside was powered on at 15:15:30, the most likely scenario is that the monitor was powered off at 13:56 versus a malfunction.The customer is using their own supplied clinical network.) the customer was informed via customer letter about the investigation results.Although the x2 in question worked as specified and intended during the onsite testing and the most likely scenario is that the monitor was powered off at 13:56, a malfunction of the device cannot be ruled out.The exact cause for the reported issue remains unknown.No further investigation or action is warranted.Patient information requested none available.

Manufacturer Narrative

Udi number added.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6438662
• MDR Text Key: 70990035
• Report Number: 9610816-2017-00099
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2017

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: M3002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: 03/03/2017; 03/03/2017
• Supplement Dates FDA Received: 07/19/2018; 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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
• Patient Outcome(s): Death