MAUDE Adverse Event Report: VIOPTIX, INC. T.OX SP SENSOR; OXIMETER, TISSUE SATURATION

Model Number OXY-2-SPD-1-P5

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Event Description

Sticky adhesive came apart from cord as we were trying to attach it to the patient.Product had patient contact but no patient harm.A new patch was opened to complete the procedure.

• Brand Name: T.OX SP SENSOR
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): VIOPTIX, INC.; 39655 eureka drive; newark CA 94560
• MDR Report Key: 9621465
• MDR Text Key: 176047737
• Report Number: 9621465
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OXY-2-SPD-1-P5
• Device Catalogue Number: OXY-2-SPD-1-P5
• Device Lot Number: D78320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1