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U.S. Department of Health and Human Services

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

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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  
Event Description
The customer reported that the device detects a saturation (spo2) above 3-4 % with respect to their other devices. There was no patient involvement.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the device detects a saturation (spo2) above 3-4 % with respect to their other devices. There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.
 
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Brand NameSURESIGNS VS2+ NBP/SPO2
Type of DevicePATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7038073
MDR Text Key122070855
Report Number1218950-2017-07845
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeIT
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,Followup
Report Date 10/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2017
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2016
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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