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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
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Event Description
The device was returned to bench repair, during evaluation the bench repair technician (brt) observed that the speaker does not work and no sound heard at all.The device was not in use on a patient at the time of the event.
 
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Brand Name
SURESIGNS VS2+ NBP/SPO2/WIRELESS
Type of Device
SURESIGNS VS2+ NBP/SPO2/WIRELESS
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 Key13193060
MDR Text Key284192804
Report Number1218950-2022-00019
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00884838028401
UDI-Public00884838028401
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K112652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number863279
Device Catalogue Number863279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2021
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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