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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 Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 09/07/2020
Event Type  Death  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that on (b)(6) 2020 a patient expired while being monitored with the patient worn device.The hospital was investigating the cardiac rhythm of the patient prior to the patient's death.
 
Manufacturer Narrative
H10: the device was not expected to be returned for evaluation.The customer did not allege a malfunction against the mx40.The device was not evaluated by a philips engineer.A conclusive log review could not be performed by philips as the logs provided did not provide data for the date of event and the customer was not able to provide product identifying or bed label information.The customer wished to perform their own investigation and was provided instructions on pulling logs for their review.The device remains at the customer site.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 Key10562341
MDR Text Key207791385
Report Number1218950-2020-05555
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865352
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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