MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3155 UPGRADE REL N.0

Model Number 865427

Device Problem Application Network Problem (2879)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

The customer biomedical engineer (biomed) reported that they had a network database indicating a loss of telemetry in the 6th and 7th floor, and had a "no signal" inop in all the sectors.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 field service engineer (fse) went onsite, and did a thorough walk through in all the sectors floors, while checking all power to the uninterruptable power supplies (ups), philips intellivue information centers (piic), routers, switches, sync units, power over ethernet (poe), and access point controllers (apcs).The fse rebooted the piic and servers.The fse connected to the user interface in the 2nd floor closet, and found that out of the three apcs on the network, only one apc was running the whole network and were on unregistered access points (aps).The fse rebooted apc3-2 ip172.31.241.2 and apc4-1 ip 172.31.241.1; the customer¿s aps were then gradually connecting to the network.The network was restored after the systems reboot.Monitoring was restored showing evidence of patient vitals appearing on the patient sectors.The customer is aware the system is end of life/ end of service (eol/eos).Based on the information available and the testing conducted, the cause of the reported problem was a network issue.The reported problem was confirmed.The device was operational after repairs were completed.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: M3155 UPGRADE REL N.0
• Type of Device: M3155 UPGRADE REL N.0
• 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: 18152741
• MDR Text Key: 328318690
• Report Number: 1218950-2023-00864
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081983
• 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

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: 865427
• Device Catalogue Number: 865427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2012
• 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