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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 Alarm (1019)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2021
Event Type  malfunction  
Event Description
The customer reported the mx40 had not sound. 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 Key11406395
MDR Text Key234725664
Report Number1218950-2021-10067
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,Followup
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/16/2021
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2019
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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