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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 Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Unable to confirm serial number.A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a "loud speaker failure" and later confirmed that there was a ¿speaker malfunction¿ inop message.It is unclear whether the device was being used on or off the network.The device was not in use on a patient.
 
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Brand Name
MX40 2.4 GHZ SMART HOPPING
Type of Device
MX40 2.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8602298
MDR Text Key144843959
Report Number1218950-2019-03417
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2019
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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