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

Model Number	863279
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Statement of the reported problem: this report is based on information provided by philips response service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the suresigns vs2+ nbp/spo2/wireless indicating that the audio failed and an inop message was displayed.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.Functional testing/service repair/technical investigation: the following functional tests were performed: the rse spoke to the customer and determined that the loss of audio was the result of a failed speaker.Confirmation: based on the information available and the testing conducted, the cause of the reported problem was a failed speaker.The reported problem was confirmed.Further action decision: based on the information available and results of additional analysis, no further action is necessary at this time.Closure & product disposition: serviceable ¿ replacement product provided: the customer placed an order for a new speaker (ss mechasy speaker assy-fs part number - 453564293611) and is taking responsibility for performing the device repair to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16101948
• Report Number: 1218950-2023-00005
• Device Sequence Number: 6186977
• Product Code: DSK
• UDI-Device Identifier: 00884838028401
• UDI-Public: 00884838028401
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K111114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2013
• 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