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

Model Number 865350

Device Problem No Audible Alarm (1019)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicate that there was no speaker sound during the start up test.The device failed a manual power on test, and speaker was defective.The cause of the reported problem was confirmed to be a defective speaker.The speaker was replaced.The device was operational after repairs were completed and the device was returned to the customer.The investigation concludes that no further action is required at this time.

Event Description

During evaluation at philips bench repair, it was identified that the device had no audio.The device was not in clinical use at the time the issue was discovered.No adverse event or harm was reported.

• 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: 18393206
• MDR Text Key: 331548368
• Report Number: 1218950-2023-00970
• Device Sequence Number: 1
• Product Code: DSI
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1