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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 PATIENT WEARABLE MONITOR
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PHILIPS MEDICAL SYSTEMS MX40 PATIENT WEARABLE MONITOR Back to Search Results
Model Number 865351
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Event Description
Customer reported a speaker malfunction.It was confirmed there was no sound present.
 
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.Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).
 
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Brand Name
MX40 PATIENT WEARABLE MONITOR
Type of Device
MX40 PATIENT WEARABLE MONITOR
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 Key18943043
MDR Text Key338261233
Report Number1218950-2024-00206
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082243
UDI-Public00884838082243
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/15/2016
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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