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

Model Number 866389

Device Problem Application Network Problem (2879)

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

Event Date 05/09/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that they lost network connection on all floors.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

Manufacturer Narrative

A philips technical consultant (tc) went to the customer site.The mobility server wymc07103 was showing to be offline, and testing was performed.Results of functional testing indicate it was a virtual server that went down.The owner rebuilt its virtual server and was run it through setup and restored to service.This was noted to by a hybrid system; the network in the hospital is a philips supplied clinical network (pscn), while the virtual server is on a customer supplied clinical network (cscn).Based on the information available and the testing conducted, the problem was confirmed; the cause of the reported problem was the customer¿s virtual server.The device was operational after repairs were completed.The investigation concludes that no further action was required at this time.

• 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: 16974786
• MDR Text Key: 315866258
• Report Number: 1218950-2023-00339
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• 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,Company Representative
• 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 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: 05/09/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• 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