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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 Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported the mx40 telemetry device displayed a speaker malfunction inop (inoperative message).The customer was not aware if the device had audible sound.The device was not in clinical use.
 
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Brand Name
MX40 1.4 GHZ SMART HOPPING
Type of Device
MX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10826229
MDR Text Key217122499
Report Number1218950-2020-06833
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082236
UDI-Public(01)00884838082236
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 user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number865350
Device Catalogue Number865350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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