MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0

Model Number 865354

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, a philips field service engineer (fse) was at the customed site, and overheard customer biomeds, while they were in contact with the emergin support group.They needed assistance from the emergin tech support to review logs, due to a patient code.The system was is use at the time the issue was discovered.The patient had coded.Patient details, are unknown at the time this report was due.

Manufacturer Narrative

There was no philips product malfunction.Based on the provided information, a customer nurse had logged into a voalte system phone, and a second nurse had logged into another voalte system phone with the same serial number.This resulted in the nurse caring for the impacted patient getting canceled from the voalte phone system; therefore, the red alarm alert did not get paged through to this nurse's phone.Further evaluation found that there were two other voalte phones that had been assigned the same serial number.The voalte representative stated that the duplicate phone should be sent back to the manufacturer, because all serial numbers should be unique.The customer will be working with voalte to correct this issue.The philips device remains at the customer site.No further investigation is warranted at this time.

• Brand Name: EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0
• Type of Device: EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0
• 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: 7251442
• MDR Text Key: 99348345
• Report Number: 1218950-2018-01441
• Device Sequence Number: 1
• Product Code: MSX
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865354
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2013
• 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 Age: 85 YR
• Patient Weight: 72