MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The customer reported that the system speaker malfunctioned.The device was in use on patient at time of event, there was no adverse event reported.

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.

Manufacturer Narrative

The customer was provided bench repair information for the device.The device was received at the philips authorized repair facility.The customer was provided information on the bench repair but declined service on the device at the time.No functional testing was performed, and the customers device was sent back unrepaired.The philips authorized repair facility provided the customer bench repair information.The customer declined the device repair and the device was returned to the customers unrepaired.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• 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: 18869896
• MDR Text Key: 337354527
• Report Number: 1218950-2024-00174
• 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
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2014
• 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