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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING
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PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING Back to Search Results
Model Number 865350
Device Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2022
Event Type  malfunction  
Event Description
It was reported during bench evaluation, the device had no audio.The device was not in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.A visual inspection of the device identified the speaker was defective.The speaker was replaced with a foxlink d speaker.The device remains at the customer site.
 
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Brand Name
MX40 1.4 GHZ SMART HOPPING
Type of Device
MX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
222 jacobs street
cambridge MA 02141
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
222 jacobs street
cambridge MA 02141
Manufacturer Contact
hisham alzayat
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key16323428
MDR Text Key309064849
Report Number1218950-2023-00078
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082236
UDI-Public00884838082236
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation 505
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865350
Device Catalogue Number865350
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received02/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2015
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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