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

Model Number	863279
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a speaker fault.The device was not in use on a patient at the time of the event.The suresigns vs2+ nbp/spo2/wireless (model number 863355) is substantially similar to the suresigns vs2+ nbp/spo2/wireless (model number 863279) and will be reported in the united states under device model number 863279 (cfn/fei # (b)(4); 510k k111114).

• Brand Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Common Device Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 12371132
• Report Number: 1218950-2021-10852
• Device Sequence Number: 19134368
• Product Code: MHX
• UDI-Device Identifier: 00884838028401
• UDI-Public: 00884838028401
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• 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
• Operator of Device: Health Professional
• Device Model Number: 863279
• Device Catalogue Number: 863279
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1