MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPHERE EVENT MANAGEMENT; COMMUNICATION SYSTEM

Model Number	866030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that room 306 alerted a vtach on (b)(6) 2019 at 9:47:03.There was a delay of alarms via the paging system.No information was received indicating the device was not a contributing factor in the event.The type of adverse event was not provided at the time of this report.
Additional Manufacturer Narrative
A philips product support engineer (pse) obtained the paging system (em) logs.The pse reviewed the logs and concluded that the system functioned as designed.The investigation found that one alarm messages was delivered from bed 306 wmc to 23 may 2019 at 09:47:20am est (iem system time) to the zetron paging terminal for pager pin¿s = 2500, 1665, 990, 9998: an examination of he overall iem system found that the computer cpu is only one core, while the minimum specifications require two cpu cores.There was no product malfunction; this is considered a user issue.The system had sent a page for the alarm on 23 may 2019 at 9:47:20am for the vtach alarm occurring at 9:47:03am on 23 may 2019.The pse also emailed the customer requesting for the iem server to have at least one more cpu core added to the computer.

• Brand Name: INTELLISPHERE EVENT MANAGEMENT
• Common Device Name: COMMUNICATION SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8686332
• Report Number: 1218950-2019-04104
• Device Sequence Number: 19388165
• Product Code: MSX
• UDI-Device Identifier: 00884838031746
• UDI-Public: (01)00884838031746
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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
• Operator of Device: Health Professional
• Device Model Number: 866030
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention