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

Model Number	863275
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer requested a loudspeaker.Additional information was requested as to why a loudspeaker was needed, but no response was received.Patient involvement is unknown.There was no reported patient or user impact.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The customer contacted the customer care solutions center(ccsc) for assistance.The philips remote support(rs) submitted the request to the quotation department.A part quotation for a loudspeaker was provided to the customer.However, as of the date of closure of this complaint, the customer has not accepted the quotation and the quote expired.A good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but there is no additional information available.A search in servicemax found no further related calls.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.H3 other text : customer has not accepted price quote for repair.
Event or Problem Description
The customer requested for a loudspeaker quote.No additional information was obtained as to why a loudspeaker was needed and if there were audible tones/alarm heard.Patient involvement is unknown.There was no reported patient or user impact.

• Brand Name: SURESIGNS VSI - NBP
• Common Device Name: SURESIGNS VSI - NBP
• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15046255
• Report Number: 1218950-2022-00606
• Device Sequence Number: 5601075
• Product Code: DXN
• UDI-Device Identifier: 00884838028364
• UDI-Public: 00884838028364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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: 863275
• Device Catalogue Number: 863275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2013
• 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