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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS VS2 NBP, SP02; PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS VS2 NBP, SP02; PATIENT MONITOR Back to Search Results
Model Number 863080
Device Problems No Audible Alarm (1019); Device Inoperable (1663); Device Displays Incorrect Message (2591)
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 completed.
 
Event Description
During preventative maintenance of the device, a philips field service engineer (fse) noted that the speaker did not work and alarms could not be heard.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 Name
VS2 NBP, SP02
Type of Device
PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
nancy ataide
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6844565
MDR Text Key85104972
Report Number1218950-2017-06062
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K082280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863080
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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