MAUDE Adverse Event Report: MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2021

Event Type  malfunction  

Event Description

The customer reports that the mx40 has a speaker malfunction inop/ error code but was unable to confirm local audio.No patient involvement.

Event Description

The customer reports that the mx40 has a speaker malfunction inop/ error code but was unable to confirm local audio.The device was not in use on a patient at the time of event.There was no adverse event reported.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• MDR Report Key: 11407965
• MDR Text Key: 234724613
• Report Number: 1218950-2021-10073
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Distributor Facility Aware Date: 02/17/2021
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• 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