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

Model Number 865352

Device Problems Inaudible or Unclear Audible Prompt/Feedback (2283); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported a speaker malfunction error message and a loss of audio on the mx40 telemetry device.It was reported the device was not in clinical use.

Manufacturer Narrative

H10: the actual device was returned to philips bench where the technician was unable to replicate the customer's allegation of no sound.The technician confirmed the device had speaker malfunction alarm and log messages; however, the audio was working.There was corrosion on the system board near the speaker connector, which caused the speaker alarm messages.Corrosion is known to be caused by improper cleaning/disinfection of the mx40/mx4j pmw and/or use of unapproved cleaning and disinfecting agents.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11265089
• MDR Text Key: 230761149
• Report Number: 1218950-2021-00689
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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: 865352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1