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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 Incorrect Measurement (1383)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/08/2022
Type of Reportable Event Malfunction
Event or Problem Description
It was reported to philips that suresigns vm 6 patient monitor had spo2 issue.The device was not in use at the time the issue was discovered.
 
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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
derek sammarco
3000 minuteman road
andover, MA 01810
9786593000
MDR Report Key14890189
Report Number1218950-2022-00533
Device Sequence Number6283527
Product Code MHX
UDI-Device Identifier00884838000056
UDI-Public00884838000056
Combination Product (Y/N)N
Initial Reporter CountryHK
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,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
Device Model Number863065
Device Catalogue Number863065
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/08/2022
Initial Report FDA Received Date07/01/2022
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/06/2012
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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