MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING; TELEMETRY PATIENT MONITOR

Model Number 865350

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)

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

Event Date 10/02/2023

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.

Event Description

A philips field service engineer (fse) reported on behalf of the customer that audible and visual notifications are affected due to battery consumption.The fse upgraded the software and confirmed the unit is working properly.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site and determined the issue was related to software defects.The fse upgraded the mx40 to resolve the reported issue.The device remains at the customer site.

Event Description

A philips field service engineer (fse) reported on behalf of the customer that audible and visual notifications are affected due to battery consumption.The fse upgraded the software and confirmed the unit is working properly.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: TELEMETRY PATIENT MONITOR
• 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: 18040547
• MDR Text Key: 326982667
• Report Number: 1218950-2023-00834
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• 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,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: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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