• 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 Problems No Audible Alarm (1019); Device Inoperable (1663)
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 device gives audio error, sound not working. There was no reported patient incident injury.
 
Event Description
The customer stated that the device gives audio error, sound not working. There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient. The device was in use at the time of the reported issue.
 
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
wendy chadbourne
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6072489
MDR Text Key59230646
Report Number1218950-2016-06885
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2016
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 Received10/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-