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

Model Number	866030
Health Effect - Clinical Code	Death (1802)
Date of Event	01/11/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient information as been requested.A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that on (b)(6) 2018, as alarming stopped through the paging (iem) system at 10:17am.The patient leads off of telemetry starting happening at 17:30pm, and no iem leads off alerts were received.At 19:00, they found the patient in room 335 in 3 south expired.The patient died.
Additional Manufacturer Narrative
The paging interface was operational and worked as expected earlier in the day between (b)(6).However, the customer said the patient had an event at (b)(6); no paging data for that bed at that time or after was available, and it is not known what the input/monitoring system was doing during that time, due to the monitoring system being a ge product, not a philips product.The pse also indicated that if the ge system monitor had a ¿leads off¿ alert, no patient data from ge would be received.However, further investigation of the report that the patient leads off of telemetry starting happening at (b)(6) and no iem leads off alerts were received, could not be performed, as the logs needed to for the investigation from ge were not available.Therefore, philips could not rule out a malfunction, or that the failure to page may have been a factor in this event.The customer was directed to have the vendor ge parse its systems logs.The customer had no further questions for philips, and confirmed that they had informed ge of the issue.No further investigation is warranted at this time.

• 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: 7215509
• Report Number: 1218950-2018-00656
• Device Sequence Number: 1110326
• Product Code: MSX
• UDI-Device Identifier: 00884838031746
• UDI-Public: (01)00884838031746(10)A.03.02
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 01/12/2018
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 05/07/2018
• 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: Death