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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  
Event Description
During product evaluation, the bench repair technician found the mx40 telemetry device had no sound. There was no patient involved.
 
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Brand NameINTELLIVUE MX40 802.11A/B/G
Type of DevicePATIENT 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 Key10449202
MDR Text Key205083807
Report Number1218950-2020-04919
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
Type of Report Initial
Report Date 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2020
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 Manufacturer07/30/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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