MAUDE Adverse Event Report: COVIDIEN OXYGEN SENSOR; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Model Number OXYGEN SENSOR

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2017

Event Type  malfunction  

Event Description

It was reported that the voltage on oxygen (o2) sensor fluctuates.The device was not in use on a patient at the time the malfunction occurred.The service engineer (se) verified the malfunction and replaced the o2 sensor.The unit passed all testing and operates within the manufacturing specifications.

• Brand Name: OXYGEN SENSOR
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: ray maroofian ; 2101 faraday ave.; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6463230
• MDR Text Key: 72127833
• Report Number: 8020893-2017-05574
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2017

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: OXYGEN SENSOR
• Device Catalogue Number: 10097559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2017
• Initial Date FDA Received: 04/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1