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

Model Number 865350

Device Problems No Audible Prompt/Feedback (2282); No Apparent Adverse Event (3189)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

The customer reported that the device displayed "speaker malfunction" message and was unsure if there was sound.The device was not in use on a patient at the time of event and there was no adverse event reported.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the device displayed "speaker malfunction" message and was unsure if there was sound.The device was not in use on a patient at the time of event and there was no adverse event reported.The philips technical consultant (tc) went onsite to confirm the event and determined the cause was the speaker malfunction.To resolve the issue, the tc replaced the mx40 due to the speaker malfunction.The device remained on site.

Manufacturer Narrative

This report was created in reference to mfr report number 1218950-2022-00719 in order to include evaluation results after product was returned.Correction: the device was replaced; therefore, did not remain on site as previously reported.

Event Description

The customer reported that the device displayed "speaker malfunction" message and was unsure if there was sound.The device was not in use on a patient at the time of event and there was no adverse event reported.The philips technical consultant (tc) went on site and replaced the mx40 due to the speaker malfunction.The device was returned for evaluation at a philips authorized repair facility.Evaluation of the device determined that the speaker did produce audible sound and no speaker malfunction was present.No further investigation or action is warranted 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: 15229834
• MDR Text Key: 298210516
• Report Number: 1218950-2022-00719
• 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,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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 12/29/2022
• Supplement Dates FDA Received: 12/20/2022; 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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