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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2/TEMP/WIRELESS PATIENT MONITOR

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PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2/TEMP/WIRELESS PATIENT MONITOR Back to Search Results
Model Number 863277
Device Problem 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 complete.
 
Event Description
The customer reported that the patient monitor audio failure displayed the customer confirmed that the device was connected to a patient when this event happened. No adverse event involving patient or user was reported,.
 
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Brand NameSURESIGNS VSI - NBP/SPO2/TEMP/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 Key8349700
MDR Text Key136610905
Report Number1218950-2019-01299
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863277
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 Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2015
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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