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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a speaker malfunction on the mx40 telemetry device.It is unknown if the device had audible sound.It was reported the device was not in clinical use.
 
Manufacturer Narrative
H10: the actual device was returned to philips bench where the technician found the audio was working.There were speaker alarm and log messages.The technician found the sound was distorted due to water intrusion.Water damage is known to be caused by improper cleaning/disinfection of the mx40/mx4j pmw and/or use of unapproved cleaning and disinfecting agents.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.
 
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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
MDR Report Key11364907
MDR Text Key234425430
Report Number1218950-2021-00884
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/02/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/02/2021
Initial Date FDA Received02/23/2021
Supplement Dates Manufacturer Received02/02/2021
Supplement Dates FDA Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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