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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 Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported that the speaker was defective.No adverse pt impact reported.
 
Manufacturer Narrative
(b)(4).A follow-up report will be submitted once the investigation is complete.
 
Manufacturer Narrative
H3: device received in a condition which made analysis impossible.Submission of a report does not constitute an admission that the 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 rd.
andover MA 01810
Manufacturer Contact
nancy ataide
3000 minuteman rd.
andover, MA 01810
9786597429
MDR Report Key4384996
MDR Text Key5361771
Report Number1218950-2014-07770
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/12/2014
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2014
Initial Date FDA Received12/24/2014
Supplement Dates Manufacturer Received12/12/2014
Supplement Dates FDA Received04/09/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2013
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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