MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VSI - NBP/SPO2

Model Number	863276
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported the problem of inconsistencies spo2 readings (sometimes high and sometimes low) there was no reported patient or user impact.
Event or Problem Description
The customer reported the problem of device reboots continuously.
Additional Manufacturer Narrative
This pr was re-evaluated based on investigation results.During investigation, it was clarified that the customer reported the issue was related to device reboots not inconsistent per initial reporting.This case is confirmed to address issue of device reboots continuously and has been deemed non-reportable.Device reboots interrupt monitoring for (~30) seconds before monitoring resumes and does not affect the measurements on the monitor.The rebooting of the monitor is detectable to users because the appearance is easily distinguished from normal monitoring.The monitor is designed to generate restart tones when restarting.These tones would allow the user to implement alternative monitoring if warranted.The device is designed to reboot when it encounters problems with the network.Once restarted, the device will return to normal monitoring.As per the definition of non-reportable, this device/product issue did not cause or contribute to death or serious injury nor would likely cause or contribute to death or serious injury upon recurrence.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Common Device Name: SURESIGNS VSI - NBP/SPO2
• 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 Key: 13839329
• Report Number: 1218950-2022-00224
• Device Sequence Number: 16494229
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Model Number: 863276
• Device Catalogue Number: 863276
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown