MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2; PATIENT MONITOR

Model Number 863276

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported an audio error.The customer confirmed that the device was connected to a patient when this event happened.There was no report of an adverse event involving patient or user.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8253103
• MDR Text Key: 133240598
• Report Number: 1218950-2019-00499
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2013
• 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