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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 802.11A/B/G; PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 802.11A/B/G; PATIENT MONITOR Back to Search Results
Model Number 865352
Device Problems Display or Visual Feedback Problem (1184); No Audible Prompt/Feedback (2282)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.Phone number (b)(4).
 
Event Description
The customer reported speaker malfunction message and a loss of audio on the mx40 telemetry device.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
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Brand Name
INTELLIVUE MX40 802.11A/B/G
Type of Device
PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11012494
MDR Text Key222016755
Report Number1218950-2020-07809
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838030350
UDI-Public(01)00884838030350
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/03/2020
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 Number865352
Device Catalogue Number865352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/03/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received12/03/2020
Supplement Dates FDA Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2017
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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