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

Model Number 865352

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the speaker's sound is not working at all; no sound can be heard from the device.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

H10: the technician found the device had audible sound during testing.The cause of the customer's allegation is unknown.At bench repair, the device was updated to the latest hardware and software per assembly procedure a-865350-90127 and a-965350-90063.At bench repair, the technician also found the device had been tampered with, the housing had been replaced with non-philips housing.There was corrosion on pin, the battery contacts were damaged, and the bezel had many scratches.Philips instructions for use and service manual for the mx40 state that if you are experiencing operational issues with the device you should contact philips directly to the report the issue.The mx40 is either exchanged or repaired by an authorized philips factory technician.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: 10562132
• MDR Text Key: 208408237
• Report Number: 1218950-2020-05554
• 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: 09/08/2020

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: 09/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1