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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS2+ NBP/SPO2

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PHILIPS NORTH AMERICA LLC SURESIGNS VS2+ NBP/SPO2 Back to Search Results
Model Number 863278
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported noisy signal¿ message appears on cve monitor screen and when the monitor is turned on the message of "audio failure" appears. The device was not in use on a patient at the time of the event.
 
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Brand NameSURESIGNS VS2+ NBP/SPO2
Type of DeviceSURESIGNS VS2+ NBP/SPO2
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
222 jacobs street
cambridge MA 02141
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
222 jacobs street
cambridge MA 02141
Manufacturer Contact
tara mackinnon
222 jacobs street
cambridge, MA 02141
MDR Report Key11719030
MDR Text Key247094783
Report Number1218950-2021-10411
Device Sequence Number1
Product Code DXN
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 user facility
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863278
Device Catalogue Number863278
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/13/2021
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated by Manufacturer? Yes
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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