MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 802.11A/B/G

Model Number 865352

Device Problem Application Program Problem (2880)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

The customer reported that the alarm limits that are set on the patient information center ix (pic ix) version 4.0 control center are then not taken over by the mx40.Consequently, the mx40 telemetry device does not alarm to the set alarm limits of the control center.It is unknown if the device was in use on a patient, but no adverse event to the patient or user was reported.The issue was escalated to a philips product support engineer for investigation and the issue was entered into the software defect database (azure devops) as sticr# 67444 for further review by the cross functional team.The investigation determined that after the mx40 restarts, if the internet protocol (ip) address of mx40 is changed, patientservice will remove and add the mx40 in a notification in pic ix 4.0.Controlservice did not expect this case (remove/add the same device) and cannot handle it correctly.This issue is corrected in software version 4.1 and later releases.This issue is not present in pic ix version c.03.This is considered a serious problem, since the user can change the alarm limit, and the pic ix displays updated alarm limit while actually mx40 still uses the original alarm limit.This is considered a pic ix software deficiency; the device failed to meet specifications.The investigation of this issue and any further actions will be determined by the cross functional team and documented in azure devops associated with the sticr.The software can be patched to resolve the issue.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

Reportability change: after further review, it was determined that the criteria for reportability was not met.The investigation determined that the cause of the issue is related to the pic ix software (reported under mfr report number 1218950-2022-01000) and there is no malfunction of the mx40 device.This record is deemed not reportable.The record was reviewed and re-evaluated to pose no health or safety risk to patients, users, or bystanders.No death, serious injury or adverse event was reported to have occurred or was alleged as a result of this issue, nor is this issue (as related to this device) likely to cause or contribute to such an event if it were to recur.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: INTELLIVUE MX40 802.11A/B/G
• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15838011
• MDR Text Key: 305592131
• Report Number: 1218950-2022-01013
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113125
• 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

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2021
• 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