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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 No Audible Prompt/Feedback (2282)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
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
During product evaluation, the bench repair technician found the mx40 telemetry device had no sound.There was not patient involvement.
 
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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
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10711395
MDR Text Key213698032
Report Number1218950-2020-06265
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,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number865352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2014
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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