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

Model Number 865351

Device Problems No Audible Alarm (1019); Inaudible or Unclear Audible Prompt/Feedback (2283)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a speaker malfunction.Effort was made to determine whether the device produced sound or not.No additional information was available at time of report.No patient involvement.

Event Description

The customer reported a speaker malfunction.During evaluation it was determine there was no sound.The device was not in use on a patient at the time of event.There was no adverse event reported.

• 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 road; andover MA 01810
• MDR Report Key: 11236892
• MDR Text Key: 229890570
• Report Number: 1218950-2021-00573
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2017
• Device Model Number: 865351
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1