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

Model Number 863276

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.(b)(6).

Event Description

The customer reported that the unit does not measure temperature.There was no reported patient impact.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 6266715
• MDR Text Key: 65679501
• Report Number: 1051786-2017-00002
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1