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

Model Number 863275

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 07/05/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

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 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
• Type of Device: 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
• MDR Text Key: 296171845
• Report Number: 1218950-2022-00606
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028364
• UDI-Public: 00884838028364
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863275
• Device Catalogue Number: 863275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2013
• 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