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 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicate that speaker had no sound and beep using speaker certification tool.The cause of the reported problem was a defective speaker.The reported problem was confirmed.He speaker was replaced.The device was operational after repairs were completed and the device was returned to the customer.

Event Description

During evaluation at bench repair, it was identified that the device had no audio.The device was not in use on a patient at the time of the event.There was no adverse event reported.

Manufacturer Narrative

This complaint was reported in error.Sound was present at bench repair and no report is needed.

• 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: 18394979
• MDR Text Key: 331342286
• Report Number: 1218950-2023-00972
• 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: Company Representative
• Reporter Occupation: 505
• Type of Report: Initial,Followup

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: 12/12/2023
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2012
• 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