MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

Customer reported a global error occur on all switches, connectivity critical : switch unreachable, starting at thu 3/21/2024 11:17 am on the philips network.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Manufacturer Narrative

A philips network engineer reviewed logs and indicated a lot of macflap in the logs, which usually indicates a loop.Unidirectional links are a common cause of a bridging loop.On fiber links, a failure that goes without detection often causes unidirectional links.Another cause is a problem with a transceiver.Anything that can lead a link to stay up and provide a one-way communication is very dangerous with regard to stp.A philips product surveillance engineer also reviewed the issue and provided the following: the allegation is attributable to network reliability concerns and not indicative of a flaw within the philips information center.( philips products are working as designed).Philips medical equipment has been engineered to meet stringent standards of performance and reliability.However, the effectiveness of these systems is contingent upon the stability and functionality of the supporting network infrastructure.This allegation is directly related to network stability.Based on the information available and the testing conducted, the cause of the reported problem was non-cisco sfp modules installed previously by the customer.The sfp modules are inserted in the switches to accommodate copper or fiber connections in the uplink ports.The reported problem was confirmed.

Event Description

Philips received a complaint on the patient information center ix indicating a global error occur on all switches, switch unreachable.The device was in clinical use.There was no patient harm reported.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19105591
• MDR Text Key: 340902197
• Report Number: 1218950-2024-00259
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2015
• 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