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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS SURESIGNS VS2+ NBP/SPO2/WIRELESS PATIENT MONITOR Back to Search Results
Model Number 863279
Device Problems No Audible Prompt/Feedback (2282); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported the problem of audio failure in monitor and speaker error. The device was not in clinical use at the time the reported issue was discovered.
 
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Brand NameSURESIGNS VS2+ NBP/SPO2/WIRELESS
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 Key11358473
MDR Text Key234218617
Report Number1218950-2021-00882
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K112652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863279
Device Lot NumberN/A
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 Received02/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2014
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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