MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS2+ NBP/SPO2

Model Number	863278
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting institution phone #:(b)(6).Reporter phone #: (b)(6).A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported the loud speaker is defective, the speaker was replaced and the problem persists.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.
Additional Manufacturer Narrative
The customer contacted the philips customer care solutions center (ccsc) for assistance.Philips technical support (ts) provided customer a part quotation for a replacement speaker.The customer did not accept the part quotation for a replacement speaker.It is not known how or if the customer's issue was resolved; therefore, we are considering this malfunction to be insufficient information/cause unknown.The device remains at the customer's facility.There have been no subsequent calls related to this issue.

• Brand Name: SURESIGNS VS2+ NBP/SPO2
• Common Device Name: SURESIGNS VS2+ 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: 13942703
• Report Number: 1218950-2022-00278
• Device Sequence Number: 14650528
• Product Code: DXN
• UDI-Device Identifier: 00884838028395
• UDI-Public: 00884838028395
• 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: 863278
• Device Catalogue Number: 863278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2016
• 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