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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 Problem Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported power-on self test detected a speaker failure during installation.There was a speaker malfunction alarm on the device.The device was not in use on a patient.
 
Manufacturer Narrative
H10: the tracking number indicates that the product was received.However, the device has been misplaced and cannot be located.If the device is located and returned to philips bench, this case will be reopened and the findings will be incorporated.The customer received a replacement device.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : the device was received for evaluation and subsequently misplaced.
 
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Brand Name
MX40 2.4 GHZ SMART HOPPING
Type of Device
MX40 2.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key10053583
MDR Text Key191246755
Report Number1218950-2020-02807
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082243
UDI-Public(01)00884838082243
Combination Product (y/n)N
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865351
Device Catalogue Number865351
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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