MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFO CENTER IX; CENTRAL STATION MONITOR

Model Number 866023

Device Problems Nonstandard Device (1420); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device repairs for implementation of field change order (b)(4).

Event Description

The customer called for assistance with an issue involving information center ix reboots.The issue occurred after january 1 2018.There was no patient incident.

• Brand Name: INTELLIVUE INFO CENTER IX
• Type of Device: CENTRAL STATION MONITOR
• 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: 7252371
• MDR Text Key: 241266211
• Report Number: 1218950-2018-01508
• Device Sequence Number: 0
• Product Code: MHX
• Reporter Country Code: US
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/12/2018
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 0