• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS2+ NBP/SPO2 PATIENT MONITOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS SURESIGNS VS2+ NBP/SPO2 PATIENT MONITOR Back to Search Results
Model Number 863278
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer stated that the speaker malfunction. There was no reported patient incident injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESIGNS VS2+ NBP/SPO2
Type of DevicePATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6102612
MDR Text Key60291383
Report Number1218950-2016-07202
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,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863278
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-