• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING Back to Search Results
Model Number 865351
Device Problem Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
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. The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMX40 2.4 GHZ SMART HOPPING
Type of DeviceMX40 2.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
derek sammarco
222 jacobs street
cambridge, MA 02141
MDR Report Key11612935
MDR Text Key243739185
Report Number1218950-2021-10283
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeMX
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/05/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865351
Device Catalogue Number865351
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/17/2021
Event Location No Information
Date Manufacturer Received03/17/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/07/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-