MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLISPACE EVENT MGMT PLATFORM

Model Number	866030
Medical Device Problem Code	Delayed Alarm (1011)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	08/16/2022
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
It was reported that there was a delay in receiving the alert for an asystole alarm from the intellispace event management (iem) system and, as a result, the patient had experienced an adverse event and it was necessary to transfer the patient to the intensive care unit (icu).
Additional Manufacturer Narrative
A philips technical service specialist spoke with the customer.The tse conducted an investigation of the philips software, and concluded that the iem 11.4 system (eol since december 31,2020 but customer is still using this in production), the philips iem message delivery history logs showed no delay.The investigation found that one alarm message was delivered from unit ¿4-east¿ bed ¿u402¿ to two output devices = 94.Lantronix - led on 4th floor, and 5089633580 verizon (snpp) on iem system log time on (b)(6) 2022@ 21:27:33.The led message was quickly cancelled (by pressing silence button on the monitor or surveillance system) the simple network paging protocol (snpp) message was already delivered to the end device and not able to be cancelled like the led can be cancelled.Investigation is still on going.Once investigation is complete a final report will be sent.
Event or Problem Description
It was reported that there was a delay in receiving the alert for an asystole alarm from the intellispace event management (iem) system and, as a result, the patient had experienced an adverse event and it was necessary to transfer the patient to the intensive care unit (icu).A philips technical service specialist spoke with the customer.The tse conducted an investigation of the philips software, and concluded that the iem 11.4 system (eol since december 31,2020 but customer is still using this in production), the philips iem message delivery history logs showed no delay.

• Brand Name: INTELLISPACE EVENT MGMT PLATFORM
• Common Device Name: INTELLISPACE EVENT MGMT PLATFORM
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 2039 concourse drive; b1-3/d6; st. louis, MO 63146 ; 7243875200
• MDR Report Key: 15403156
• Report Number: 1218950-2022-00872
• Device Sequence Number: 4947362
• Product Code: MSX
• UDI-Device Identifier: 00884838031746
• UDI-Public: 00884838031746
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

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
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 10/11/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/11/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown