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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 Problems No Display/Image (1183); Incorrect, Inadequate or Imprecise Resultor Readings (1535); No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

Product return date is unknown. This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review. 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.

 
Event Description

The customer reported the power on self test (post) failed; the device showed a white screen and had no audio. The device was not in clinical use at the time of the event.

 
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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
kimberly shelly
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11715246
MDR Text Key249429640
Report Number1218950-2020-06488
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 04/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/23/2021
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? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/02/2014
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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