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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING

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PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING Back to Search Results
Model Number 865351
Device Problem No Audible Alarm (1019)
Patient Problem No Patient Involvement (2645)
Event Date 02/25/2021
Event Type  Malfunction  
Event Description

The hospital's biomed reports the mx40 telemetry device had no sound even on the max volume setting. Biomed confirms that there was no sound from the speaker, volume was set to max. No patient involvement.

 
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Brand NameMX40 2.4 GHZ SMART HOPPING
Type of DeviceMX40 2.4 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 Key11415165
MDR Text Key238646110
Report Number1218950-2021-10075
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
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 Received03/04/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number865351
Device Catalogue Number865351
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/15/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/25/2021
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/20/2016
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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