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.

Manufacturer Narrative

A philips remote service engineer (rse) received email from a philips field service engineer (fse) on the behalf of the customer.In the email, the customer confirmed that the central monitoring was down for approximately one hour.The customer informed that the system big server was updated to 4.2 on (b)(6) 2022.On (b)(6) 2024 there was a failure in the cardio system and this time, it was on station w43a which was installed approx.3 to 4 weeks ago.At around 11:40 am, the customer tried to log in to the configuration but it did not work.The mouse clicks were unsuccessful followed by screen freeze.The customer waited for about 2 minutes and then did a hard reset.The customer requested to look in the logs to see if anything stood out.The customer had about 500 beds on the system so far, and another 200 would be added.The logs were checked and failure confirmed.The information collected about the outage was provided to the factory for further investigation and the case was escalated.A philips product specialist engineer (pse) identified the 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 at 2:24.The logs were provided to philips r&d for further investigation and to identify cause of the fail.Based on the investigation by philips research and development team (r&d), the issue was caused due to memory corruption either at the operating system (os) or in the memory hardware.There was also a less likely chance that it could be the cpu registers.The points of failure for the various processes were all in hash code generation, which was not something that philips control for most objects in memory.Philips had a similar case last year, where finally a cpu replacement solved the reported issue.The pse recommended the customer to monitor the box.If the error or similar issue occurred again, the pse requested the customer to replace the hardware which would be cpu & memory.The cause of the reported problem was due to memory corruption either at the operating system (os) or in the memory hardware.The reported problem was confirmed.The engineer provided information to the customer to resolve the reported issue.510 k is corrected to k211900.

• 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

• 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
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/27/2024
• 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