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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VSI - NBP

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PHILIPS NORTH AMERICA LLC SURESIGNS VSI - NBP Back to Search Results
Model Number 863275
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
Event Type  malfunction  
Event Description
The customer requested a loudspeaker. Additional information was requested as to why a loudspeaker was needed, but no response was received. Patient involvement is unknown. There was no reported patient or user impact.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
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Brand NameSURESIGNS VSI - NBP
Type of DeviceSURESIGNS VSI - NBP
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
jeanne ahearn
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key15046255
MDR Text Key296171845
Report Number1218950-2022-00606
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00884838028364
UDI-Public00884838028364
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863275
Device Catalogue Number863275
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/08/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/23/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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