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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer alleged there was no audio from the mx40. There was no report of a patient injury or harm.
 
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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
wendy chadbourne
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6663681
MDR Text Key78367333
Report Number1218950-2017-04220
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeCA
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,Followup
Report Date 06/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number865352
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2016
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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