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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 Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
The customer requested instructions for use.It was unknown if the device was in use at the time of the event.
 
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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
kimberly shelly
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11686489
MDR Text Key248395889
Report Number1218950-2020-07360
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 user facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/06/2018
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
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/06/2018
Initial Date FDA Received04/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2015
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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