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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 6 PATIENT MONITOR
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PHILIPS NORTH AMERICA LLC SURESIGNS VM 6 PATIENT MONITOR Back to Search Results
Model Number 863065
Medical Device Problem Code No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/02/2022
Type of Reportable Event Malfunction
Event or Problem Description
It was reported to philips that vm6 needed repair.After good faith effort response was received on 20apr2022, philips became aware that vm6 had audio defect.According to the third good faith effort response the device was during a test of device performed by nurse at the time the issue was discovered.No adverse event or patient harm was reported.
 
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Brand Name
SURESIGNS VM 6 PATIENT MONITOR
Common Device Name
SURESIGNS VM 6 PATIENT MONITOR
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
tara mackinnon
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key14250176
Report Number1218950-2022-00374
Device Sequence Number17242800
Product Code MHX
UDI-Device Identifier00884838000056
UDI-Public00884838000056
Combination Product (Y/N)N
Initial Reporter CountryEZ
PMA/510(K) Number
K123900
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,User Facility
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number863065
Device Catalogue Number863065
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/20/2022
Initial Report FDA Received Date04/29/2022
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured02/28/2012
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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