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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 Problems Display or Visual Feedback Problem (1184); No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a speaker malfunction inop being displayed and no audible tone when mx40 is powered on.The device was not in use on a patient at the time of event.
 
Manufacturer Narrative
H10: a good faith effort was made to obtain the device for evaluation where it was advised it is unknown if the device will be returned.The device was not received at the philips repair bench for evaluation.A philips field service engineer was not dispatched to confirm the issue and identify its cause.In the event that the device is returned or evaluated by a philips engineer, this complaint will be reopened for further evaluation.The customer was sent a replacement device.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 Key11065977
MDR Text Key224119906
Report Number1218950-2020-08049
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
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? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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