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

Model Number 865350

Device Problem No Device Output (1435)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Results of functional testing indicate that the speaker produced sound on the certification tool station.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.Although the speaker was confirmed to be functioning per specification during testing it was indicated that there was no sound at the time of the event, the speaker has been replaced per current process.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the mx40 1.4 ghz smart hopping indicating that the unit does not have any sound, no additional information available.The device was not in use on a patient at the time of the event.

• 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: 17777253
• MDR Text Key: 323814499
• Report Number: 1218950-2023-00669
• 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: User Facility,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

• 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
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• 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