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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 Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
During evaluation at bench repair, it was identified that the device had no audio.The device was not in use on a patient at the time of the event.No adverse event was reported.
 
Manufacturer Narrative
The device was sent to philips authorized repair facility (rft) for bench evaluation.Results of functional testing indicate no speaker sound at start up test.Based on the information available and the testing conducted, the cause of the reported problem was a defective speaker.The customer was provided with a replacement device to resolve the issue.
 
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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 Key18683452
MDR Text Key335073301
Report Number1218950-2024-00093
Device Sequence Number1
Product Code DSI
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
Date FDA Received02/12/2024
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
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2012
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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