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

Model Number 863279

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 308720864
• Report Number: 1218950-2023-00005
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00884838028401
• UDI-Public: 00884838028401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 863279
• Device Catalogue Number: 863279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1