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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING

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PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING Back to Search Results
Model Number 865350
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Patient Involvement (2645)
Event Date 02/17/2021
Event Type  malfunction  
Event Description
The customer reports that the mx40 has a speaker malfunction inop/ error code but was unable to confirm local audio. No patient involvement.
 
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Brand NameMX40 1.4 GHZ SMART HOPPING
Type of DeviceMX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
derek sammarco
222 jacobs street
cambridge, MA 02141
MDR Report Key11407965
MDR Text Key234724613
Report Number1218950-2021-10073
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 faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number865350
Device Catalogue Number865350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/17/2021
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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