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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING

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PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING Back to Search Results
Model Number 865351
Device Problems Display or Visual Feedback Problem (1184); No Audible Prompt/Feedback (2282)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a speaker malfunction message which is considered as a loss of audio on the mx40 telemetry device unless other information is presented or uncovered. 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 MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8452777
MDR Text Key139969957
Report Number1218950-2019-02329
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K113125
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
Report Date 03/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number865351
Device Catalogue Number865351
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2017
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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