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

Model Number 863276

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

The customer originally reported the problem of device is not working and requested a fse onsite for further evaluation/troubleshooting.Upon inspection of the device, the fse observed that the device displayed a "speaker malfunction".Additional information received from the fse confirmed that, the device displayed speaker malfunction error and there was no sound heard.There was no reported patient/user harm.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Type of Device: SURESIGNS VSI - 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: 15209767
• MDR Text Key: 297704812
• Report Number: 1218950-2022-00708
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863276
• Device Catalogue Number: 863276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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