MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE EVENT MGMT PLATFORM

Model Number	866030
Medical Device Problem Codes	Defective Alarm (1014); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was no red alarm on central monitoring.It is unknown if the device was in use at time of event, and there was no adverse event reported.
Additional Manufacturer Narrative
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.E1: reporter phone number (b)(6).
Additional Manufacturer Narrative
Philips received a complaint on the intellispace event mgmt platform, indicating that the central monitor is not displaying any red alarms.Good faith effort (gfe) was performed clarified that there was no issue with the alarming from the central station, but paging to the led is not working.The device was in use on patient at time of event, there was no adverse event reported.A field service engineer(fse) went onsite and was able to confirm that all alarms were being sent correctly from the devices to the picix at all times; however, there was a problem with communication between the emergin system and the informational led sign.After various tests, restarting the services on the emergin, the issue was resolved and the necessary tests were carried out.Based on the information available and the testing conducted, the cause of the reported problem was a communication issue between the emergin system and the informational led sign.The reported problem was confirmed a review of the global decision tree was performed and although this case was initially reported due to alarm failure, upon receipt of additional information, the issue would no longer be considered reportable.The intended use of intellisphere event management is to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events).The product can route all or subsets of this information to selective remote devices such as pagers, phones or marquees.Receipt of alarm messages or events by the external device is not confirmed and delivery to the end device is not guaranteed.The primary alarm notification is the device producing the alarm or event.This product line is not intended to provide real-time information nor is it a source of patient alarms, nor is it a replacement for alarming devices.Therefore, this issue would not be likely to cause or contribute to death or serious injury if the paging device is used per product labeling.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.

• Brand Name: INTELLISPACE EVENT MGMT PLATFORM
• Common Device Name: INTELLISPACE EVENT MGMT PLATFORM
• 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19425278
• Report Number: 1218950-2024-00393
• Device Sequence Number: 7156623
• Product Code: MSX
• UDI-Device Identifier: 00884838031746
• UDI-Public: (01)00884838031746
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866030
• Device Catalogue Number: 866030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown