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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 2.4GHZ
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PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 2.4GHZ Back to Search Results
Model Number 865351
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2024
Event Type  malfunction  
Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the system has no audio.The device was not in use on a patient at the time of event, there was no adverse event reported.
 
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Brand Name
INTELLIVUE MX40 2.4GHZ
Type of Device
INTELLIVUE MX40 2.4GHZ
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
Manufacturer Contact
hisham alzayat
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key19108835
MDR Text Key340899805
Report Number1218950-2024-00262
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082243
UDI-Public00884838082243
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 Health Professional,User Facility
Reporter Occupation Other
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 Model Number865351
Device Catalogue Number865351
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/18/2024
Initial Date FDA Received04/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2014
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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