MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VSI - NBP/SPO2

Model Number	863276
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A final report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported the problem of audio failure message and speaker fault appears in the message panel.There was no reported patient impact / injury.
Additional Manufacturer Narrative
The customer contacted the customer care solutions center (ccsc) for troubleshooting/ evaluation of the device.The ccsc provided the customer with a quote for a replacement speaker assembly.A good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.
Event or Problem Description
The customer reported the problem of audio failure message and speaker fault appears in the message panel.It is unknown if the device was in use on a patient at the time of the event.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Common Device Name: SURESIGNS VSI - NBP/SPO2
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11607800
• Report Number: 1218950-2021-10265
• Device Sequence Number: 11586036
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• 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: 863276
• Device Catalogue Number: 863276
• Distributor Facility Aware Date: 03/23/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1