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

Model Number 865350

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported receiving a speaker malf inop involving their mx40 device.No patient involvement.

• 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 road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8419914
• MDR Text Key: 138784183
• Report Number: 1218950-2019-02001
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• 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