MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problems No Audible Alarm (1019); Defective Device (2588)

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

Event Date 01/13/2023

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.(b)(6).

Event Description

The customer reported a speaker malfunction.It is unknown if the device was in clinical use at the time the issue was discovered.  there was no adverse event or patient harm reported.

Manufacturer Narrative

It is reported the device is in transit to the repair facility.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

Additional information was received which confirmed the device displayed a speaker malfunction message and had no audible sound.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

Manufacturer Narrative

The customer was provided a replacement device.Attempts were made to have the complaint device returned for evaluation; however, there was no response, and the device has not been returned.

Manufacturer Narrative

H4 device manufacture date was corrected from (b)(6) 2016 to (b)(6) 2016.The device was returned to the philips authorized repair facility.Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicate that the speaker produced no sound and the speaker was defective.Based on the information available and the testing conducted, the cause of the reported problem was a defective speaker.The customer was previously provided a replacement device.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 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: 16270408
• MDR Text Key: 308755011
• Report Number: 1218950-2023-00055
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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