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

Model Number	866030
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	01/26/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
A philips remote product support specialist (pss) spoke with the customer.And identified that philips (b)(4) as intellispace event management (iem) is end of life (eol) and provided the eol notice.The pss joined the customers webex to review the iem logs with the customer.The parsed philips paging.Log review showed the alert(s) sent to event management that were not delivered successfully.Logs show no alerts received for the bed 09b all day 1/26/22.One bed number higher and lower did receive other alerts proving iem was processing as expected.The investigation found that zero patient alarm messages and zero cancelled messages were delivered from unit: 7an with bed: 09b on (b)(6) 2022 6:45am till 5pm est.The customers message logs proved no pager(s) were assigned for this bed.There was no product malfunction; this is considered a user issue as pagers were not assigned by the user.Information was provided to the customer to resolve the issue.No further investigation or action is warranted at this time.
Event or Problem Description
Hold smp 2.24 it was reported that alarms were not paged for bed 09b on (b)(6) 2022 between 06:45 and 19:00 resulting in a patient death.
Additional Manufacturer Narrative
A philips remote product support specialist (pss) spoke with the customer.And identified that philips careevent as intellispace event management (iem) is end of life (eol) and provided the eol notice.The pss joined the customers webex to review the iem logs with the customer.The parsed philips paging.Log review showed the alert(s) sent to event management that were not delivered successfully.Logs show no alerts received for the bed 09b all day (b)(6) 2022.One bed number higher and lower did receive other alerts proving iem was processing as expected.The investigation found that zero patient alarm messages and zero cancelled messages were delivered from unit: 7an with bed: 09b on (b)(6) 2022 6:45am till 5pm est.The customers message logs proved no pager(s) were assigned for this bed.There was no product malfunction; this is considered a user issue as pagers were not assigned by the user.Information was provided to the customer to resolve the issue.No further investigation or action is warranted at this time.
Event or Problem Description
It was reported that alarms were not paged for bed 09b on (b)(6) 2022 between 06:45 and 19:00 resulting in a patient death.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13591204
• Report Number: 1218950-2022-00151
• Device Sequence Number: 3860815
• Product Code: MSX
• UDI-Device Identifier: 00884838031746
• UDI-Public: 00884838031746
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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

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?: No
• 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: 01/27/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2018
• 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: Death
• Patient Sex: Unknown