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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING
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PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING Back to Search Results
Model Number 865350
Device Problem No Audible Alarm (1019)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported the mx40 telemetry device did not have audible sound.The device was in clinical use.
 
Manufacturer Narrative
H10: the actual device was returned to philips bench where the technician was unable to replicate the customer's issue.The technician found the device had sound however, it was very distorted.There was corrosion on the speaker connector and speaker wires causing the audio distortion.Corrosion is known to be caused by improper cleaning/disinfection of the mx40/mx4j pmw and/or use of unapproved cleaning and disinfecting agents.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
MX40 1.4 GHZ SMART HOPPING
Type of Device
MX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key10934727
MDR Text Key219523817
Report Number1218950-2020-07395
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 health professional,user faci
Type of Report Initial,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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