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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 Inaudible or Unclear Audible Prompt/Feedback (2283)
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 there was no sound on the mx40 telemetry device.The device was in use on a patient.There was no patient involvement.
 
Manufacturer Narrative
H10: the device has been misplaced and cannot be located, therefore, as of 28jan-2021, the device has not been evaluated by philips bench for evaluation.If the device is located and evaluated by philips bench, this case will be reopened and the findings will be incorporated.The device was removed from service.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.H3 other text : the device was received at philips bench repair and subsequently misplaced.
 
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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 Key10809784
MDR Text Key216894698
Report Number1218950-2020-06753
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 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
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 Manufacturer11/10/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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