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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 Problem Improper Device Output (2953)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Event Description

At the repair bench it was found that there was no audio from the speaker. There was no patient involvement. There was no patient harm reported by the customer. It is unclear whether the device was being used on or off the network at the customer site. If the device is being used off network, in local monitor mode with no central station monitoring, and staff are not observing the device display, in the presence of life-threatening events when no sound is audible, serious injury and/or death can occur.

 
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Brand NameMX40 1.4 GHZ SMART HOPPING
Type of DeviceMX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
nancy ataide
3000 minuteman road
andover, MA 01810
MDR Report Key5469707
MDR Text Key39375641
Report Number1218950-2016-01313
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
Report Date 02/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/01/2016
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 Manufacturer02/24/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/07/2013
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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