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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS2+ NBP/SPO2/WIRELESS
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PHILIPS NORTH AMERICA LLC SURESIGNS VS2+ NBP/SPO2/WIRELESS Back to Search Results
Model Number 863279
Medical Device Problem Code No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/26/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event or Problem Description
The customer reported the problem of audio failure in the monitor, speaker error.Patient involvement is unknown.There was no report of patient or user harm.
 
Event or Problem Description
The customer reported the problem of an audio failure in the monitor.Patient involvement is unknown.
 
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Brand Name
SURESIGNS VS2+ NBP/SPO2/WIRELESS
Common Device Name
SURESIGNS VS2+ NBP/SPO2/WIRELESS
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
MDR Report Key11938839
Report Number1218950-2021-10629
Device Sequence Number4548194
Product Code DXN
UDI-Device Identifier00884838028401
UDI-Public00884838028401
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K112652
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
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 Number863279
Device Catalogue Number863279
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date05/26/2021
Initial Date Received by Manufacturer 05/26/2021
Supplement Date Received by Manufacturer05/26/2021
Initial Report FDA Received Date06/04/2021
Supplement Report FDA Received Date07/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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