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 04/09/2024

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.Corrected data: e1: reporter institution phone number (b)(6).E1: reporter phone number +(b)(6).

Event Description

The customer reported that there was a failure of the sectors and total monitoring control center for multiple units.It is unknown if the device was in use at time of event, and there was no adverse event reported.

Manufacturer Narrative

Additional information was received providing the software version (c.03.07.047) and confirming that the network was a customer owned network (cscn), not a philips network.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

Philips received a complaint on the patient information center ix indicating that "there was a failure of the sectors and total monitoring control center for multiple units".It is known that the device was in use at the time of the event.No adverse event occurred.The following communications were performed: a philips remote service engineer (rse) spoke with the customer and the customer alleged that there was a failure of the sectors and total monitoring control center for multiple units.The rse informed the customer that the monitors that cause the problems had the software version of 1/1/2011.The rse advised the customer to patch the monitors with the latest software version of revision n (pic system + host).The customer¿s biomedical engineer updated all x3 and mx750 to the last software revision.N.The biomed also restarted the control center.The customer confirmed that after the update of the pic system and host monitors, there were no transmission problems.Based on the information available and the testing conducted, the cause of the reported problem was due to the old software patch revision.The reported problem was confirmed.Analysis was performed and investigation has been completed.The customer¿s biomedical engineer updated all x3 and mx750 to the last software revision.N and also restarted the control center to resolve the issue.The investigation concludes that no further action is 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19112168
• MDR Text Key: 340841435
• Report Number: 1218950-2024-00257
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2020
• 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