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	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that at startup of the device, it displayed an error message "audio failure, loudspeaker defect".The device does not emit any sound.It is unknown if the device was in use on a patient at the time of the event.There was no report of patient or user harm.
Additional Manufacturer Narrative
The device did not behave as expected by the customer.To resolve the issue, the customer was provided with a replacement speaker.The absence of further calls supports that the reported problem was resolved.The device remains at the customer's facility.No further action or investigation is warranted based on the available information at the time of complaint closure.
Event or Problem Description
The customer reported that at startup of the device, it displayed an error message "audio failure, loudspeaker defect".The device does not emit any sound.It is unknown if the device was in use on a patient at the time of the event.There was no report of patient or user harm.

• 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: 11620647
• Report Number: 1218950-2021-10315
• Device Sequence Number: 19653204
• 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
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/30/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1