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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 Break (1069); 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 the mx40 telemetry device had a broken speaker.The customer was unable to confirm if the device had audible sound.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Event Description
The customer reported the mx40 telemetry device had a broken speaker.The customer was unable to confirm if the device had audible sound.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
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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 Key10670980
MDR Text Key212469725
Report Number1218950-2020-06064
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082236
UDI-Public(01)00884838082236
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 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/20/2018
Device Model Number865350
Device Catalogue Number865350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Was the Report Sent to FDA? No
Date Manufacturer Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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