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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported the device displayed a speaker malfunction inop. There was no adverse event reported.
 
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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
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key9134820
MDR Text Key164883356
Report Number1218950-2019-07446
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
Report Date 09/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2019
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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