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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 Component Missing (2306); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer reported a "speaker malfunction" error message which typically means that there is no audio from the mx40.It is unclear whether the device was being used on or off the network.There was no patient involvement.
 
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a "speaker malfunction" error message which typically means that there is no audio from the mx40.It is unclear whether the device was being used on or off the network.There was no patient involvement.
 
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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
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
MDR Report Key4878826
MDR Text Key6263118
Report Number1218950-2015-03437
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,health professional,use
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2015
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 Manufacturer09/24/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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