FDA Adverse Event Malfunction Summary report: N

MX40 1.4 GHZ SMART HOPPING

MDR report key: 5233794 · Received November 18, 2015

Report

Report Number
1218950-2015-06215
Event Type
Malfunction
Date Received
November 18, 2015
Report Date
November 2, 2015
Manufacturer
PHILIPS MEDICAL SYSTEMS
Product Code
DSI
PMA / PMN Number
K113125
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CT, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

THE CUSTOMER REPORTED NO AUDIO FROM THE MX40. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF A PATIENT INJURY OR HARM

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
763403 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

Patients

Seq Age Sex Outcome Treatment
1