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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS3 NBP, SPO2, TEMP, REC
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PHILIPS NORTH AMERICA LLC SURESIGNS VS3 NBP, SPO2, TEMP, REC Back to Search Results
Model Number 863074
Device Problem High Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2022
Event Type  malfunction  
Event Description
During testing of the device, the fse found that the spo2 sensor failed.Additional information received from the fse confirmed that the spo2 sensor is giving erratic readings ranging from high to low.Pr (b)(4) will address thermometer broken and device does not hold a charge.The device was in ot in use at time of event.There was no reported patient or user impact.
 
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Brand Name
SURESIGNS VS3 NBP, SPO2, TEMP, REC
Type of Device
SURESIGNS VS3 NBP, SPO2, TEMP, REC
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
tara mackinnon
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key15216786
MDR Text Key297778552
Report Number1218950-2022-00713
Device Sequence Number1
Product Code DSJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863074
Device Catalogue Number863074
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/27/2022
Initial Date FDA Received08/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2010
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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