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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Serial number not provided. A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the patient monitor with speaker failure. The customer confirmed that the device was not connected to a patient when this event happened.
 
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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 Key8174047
MDR Text Key130717412
Report Number1218950-2018-09808
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeTU
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 11/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
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 Received11/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2016
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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