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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 Defective Component (2292)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
Event Type  malfunction  
Manufacturer Narrative
Initial report (b)(6).
 
Event Description
The customer reported speaker malfunction. There was no further information provided by the customer. Additional information is being requested. There was no reported patient or user harm.
 
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Brand NameSURESIGNS VS2+ NBP/SPO2
Type of DeviceSURESIGNS VS2+ NBP/SPO2
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 street
cambridge, MA 02141
MDR Report Key11376220
MDR Text Key241399011
Report Number1218950-2021-10021
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K112652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/11/2021
Event Location No Information
Date Manufacturer Received02/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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