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 01/11/2024

Event Type  malfunction  

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.E1 reporting address state: (b)(6).E1 reporting institution phone #: (b)(6).E1 reporter phone #: (b)(6).

Event Description

A philips field specialist reported on the customer's behalf there was a system failure for more than one hour.The device was reported to be in use on a patient.No adverse event to the patient or user was reported.A philips remote service engineer (rse) checked the logs and confirmed the failure.The case was escalated and the collected information regarding the outage was forwarded for investigation.There were additional reports of network loss including health level 7 (hl7) transmission loss and failures on the bed-to-bed overview at the site.The escalation team identified an unhandled exception, which caused philips.Ix.Databridgehost to fail and subsequently also philips.Pmp.Dbenginehost.Exe to fail.The system was not able to recover and was restarted forcefully.The logs were provided to research and development for further investigation and to identify the cause of the fail.

• 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: 18646069
• MDR Text Key: 334590644
• Report Number: 1218950-2024-00083
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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