MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS4 NBP, SPO2

Model Number 863283

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device did not behave as expected by the customer.The customer contacted the customer care solutions center (ccsc) for assistance.Per the case notes, the customer stated he replaced the speaker once and the problem returned shortly after.The customer requested the main board and speaker under contract.The replacements main board and speaker were sent to the customer.To resolve the issue, the customer replaced the mainboard and speaker.A search in servicemax found no further related calls.The absence of further calls supports that the reported problem has not recurred.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 Description

The customer reported "audible alarms do not sound" and speaker malfunction.The device was not in use on a patient at the time of the event.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: SURESIGNS VS4 NBP, SPO2
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13193394
• MDR Text Key: 284192648
• Report Number: 1218950-2022-00020
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2019
• 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