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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING

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PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING Back to Search Results
Model Number 865351
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review.

 
Event Description

The customer called to request implementation of the fco. The device was not in use at the time of the event.

 
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Brand NameMX40 2.4 GHZ SMART HOPPING
Type of DeviceMX40 2.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
kimberly shelly
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11699684
MDR Text Key249013917
Report Number1218950-2020-07173
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 05/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/21/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865351
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/22/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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