MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) OXYGEN PARTIAL PRESSURE (PTO2) MONITOR; PTO2 MONITORING

Catalog Number LCX02

Device Problems Improper Device Output (2953); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Event Description

It was reported that when using the licox monitor with the probe and tunneled introducer, "the pbo2 value rolls on the licox when the value transferred to the patient's bedside monitor provides an average of the host that the licox roll between".This has happened on three occasions.It only happens when using the tunneled introducer.It works excellent when using the bolt.It has happened every time they use an tunneled introducer.

Manufacturer Narrative

Investigation completed 12/13/2017.The dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.Date of manufacture: 2016¿july.The product was returned and the evaluation was unable to conclusively verify the complaint as valid.Additionally, the log file of the device was reviewed and did not identify any errors applicable to the complaint incident.The evaluation was unable to conclusively verify the complaint as valid.Therefore, root cause is undetermined.

• Brand Name: OXYGEN PARTIAL PRESSURE (PTO2) MONITOR
• Type of Device: PTO2 MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7123416
• MDR Text Key: 95638017
• Report Number: 3006697299-2017-00152
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K131184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LCX02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1