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 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported the device had no audio.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.

Manufacturer Narrative

It was reported the device had no audio.The device was not in clinical use at the time of the event.The device was sent to a philips authorized repair facility that performed diagnostic/functional testing.  results of the functional testing indicate that there was no speaker sound at the start up test and the speaker was defective.The repair facility replaced the speaker.Based on the information available and the testing conducted, the cause of the reported problem was a defective speaker.   the investigation concludes that no further action is required at this time.

• 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: 18244555
• MDR Text Key: 329454642
• Report Number: 1218950-2023-00898
• 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

• 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
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2019
• 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