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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 Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  Malfunction  
Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

 
Event Description

The customer reports that the mx40 has a "speaker malfunction" inop/ error code but was unable to confirm local audio. The device was not in use on a patient at the time of the event.

 
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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 Key11647837
MDR Text Key244847472
Report Number1218950-2021-10340
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/12/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865350
Device Catalogue Number865350
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/08/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/06/2021
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/26/2016
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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