FDA Adverse Event Malfunction Summary report: N

MX40 2.4 GHZ SMART HOPPING

MDR report key: 3945296 · Received May 6, 2014

Report

Report Number
1218950-2014-02476
Event Type
Malfunction
Date Received
May 6, 2014
Report Date
April 9, 2014
Manufacturer
PHILIPS MEDICAL SYSTEMS
Product Code
DSI
PMA / PMN Number
K113125
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SW
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

THE CUSTOMER REPORTED NO AUDIO FROM THE MX40. THERE WAS NO REPORT OF PT HARM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
271445 MX40 2.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865351

Patients

Seq Age Sex Outcome Treatment
1