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

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 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 MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING Back to Search Results
Model Number 865350
Device Problem Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The customer reported that their mx40 device was silencing alarms on it's own/without user interaction. No patient harm was reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMX40 1.4 GHZ SMART HOPPING
Type of DeviceMX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
richa shah
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key5959351
MDR Text Key55067347
Report Number1218950-2016-05814
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865350
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/08/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/10/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-