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

Model Number	863278
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 a speaker malfunction and that the speaker needs to be replaced.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: SURESIGNS VS2+ NBP/SPO2
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10949505
• Report Number: 1218950-2020-07483
• Device Sequence Number: 13985175
• Product Code: DXN
• UDI-Device Identifier: 00884838028395
• UDI-Public: (01)00884838028395
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 863278
• Device Catalogue Number: 863278
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1