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 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) went onsite and confirmed the reported problem.The biomed informed fse of intermittent problems on the third floor, with some sectors displaying "no data tele." in primarily, rooms 1361, 1358, 1343, 1302, and 1364.A fse checked the rssi signal strength near one of the affected rooms and informed that the signal was strong and stable, suggesting that access points and sync units were functioning properly.A fse further inspected and found that the idf closet's its equipment, particularly two switches labeled "3402.Ax1.R.67" and "3402.Ax2.R.68." both had their uplink ports to distribution b in an error-disabled state, which could potentially affect the its, as its traffic routes through distribution b via stp.A fse suspects that it could be an issue but couldn't be able to confirm the root cause.These uplink ports on the third floor were re-enabled.There were no subsequent reports of outage on the third floor.A fse proceeded with the troubleshooting at the later stage and found three other floors 2, 4, and 5 experienced problems overnight.A fse conducted a network scan to check for any other uplinks in an error state and found that five additional switches were in error status and made the changes to switches to work normally.The affected switches served floor 2, 4 and 5.The errors were resolved.The investigation established that several uplink ports were err-disabled which caused the network to flow differently.Once the uplinks were turned back on to have a full redundant network the customer stopped experiencing issues with the tele waves dropping.The cause of the reported problem is network related.The reported problem was confirmed.The device was operational after network uplink ports were re-enabled.

Event Description

The customer reported multiple events of connection loss across multiple floors.The device was in use on the patient at the time of the event.There was no adverse event 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18735636
• MDR Text Key: 336748678
• Report Number: 1218950-2024-00114
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183387
• 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

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 Operator: Health Professional
• 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: 01/25/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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