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

Model Number 866389

Device Problem Intermittent Communication Failure (4038)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

The customer reported that nth primary centrals dropped.During this time frame, all hosts located outside of the data center experienced an inability to establish communication with the primary server.While the physio monitors could still connect to the primary server, none of the surveillance and overview stations had this capability.The problem appeared to impact all north sites within our network.While philips devices provide mitigations related to the loss of centralized wireless monitoring (ie ¿no central mon¿ inop, visual and audible tones, local monitoring for mx40), a malfunction that leads to the loss of monitoring for numerous patients using mixed wireless devices may result in a delayed response to an individual patient requiring emergent care.The device was in use.There was no report of patient or user harm.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

There was a critical communication breakdown between the central monitoring stations on the nth primary and the server.Philips is also verifying the status of the est primary server to confirm the issue.During this time frame, all hosts located outside of the data center experienced an inability to establish communication with the primary server.While the physio monitors could still connect to the primary server, none of the surveillance and overview stations had this capability.The problem appeared to impact all north sites within the network.Logs were pulled and reviewed by the field service engineer (fse).While looking at the logs, it was determined that the root cause of the network communication breakdown was due to the customer network connectivity across their wan links.Per resolution, the customer was provided with the evidence of the outcome of the findings.However, the technical consultant (tc) to provide the national support specialist (nss) with the focalpoint logs to run through software and investigate the past weeks of outages.Nss involved in checking drops or scanning errors.The engineer provided their analysis findings, and it was concluded that the cause of the communication breakdown issue may be due to the customer network.Further investigation is been done by the nss.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 18084356
• MDR Text Key: 327534006
• Report Number: 1218950-2023-00845
• 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: K183387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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 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: 10/17/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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