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

Model Number 866030

Device Problem Delayed Alarm (1011)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event 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.

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
• Type of Device: COMMUNICATION SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8686332
• MDR Text Key: 147568449
• Report Number: 1218950-2019-04104
• Device Sequence Number: 1
• Product Code: MSX
• UDI-Device Identifier: 00884838031746
• UDI-Public: (01)00884838031746
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention