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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the patient monitor had a speaker malfunction.No patient involvement.
 
Manufacturer Narrative
H10: there have been several attempts made to obtain this device for further investigation, however, as of 19mar2021, the device has not been received and/or evaluated by the factory repair bench, therefore, the complaint allegation cannot be confirmed.The customer received a replacement device.In the event that the device is returned for evaluation and/or additional information is obtained, this complaint file will be reassessed and updated accordingly.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.
 
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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
MDR Report Key11208534
MDR Text Key229087018
Report Number1218950-2021-00433
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082236
UDI-Public(01)00884838082236
Combination Product (y/n)N
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865350
Device Catalogue Number865350
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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