MAUDE Adverse Event Report: COVIDIEN E360 VENTILATOR; CONTINUOUS VENTILATOR

Model Number E360

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem High Oxygen Saturation (2478)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Third party biomed inspected the device and performed the oxygen (o2) sensor calibration.The ventilator passed the o2 calibration and return the ventilator to service.

Event Description

It was reported that during ventilator set up, the fraction of inspired oxygen (fio2) was high.The ventilator was not in use on a patient at the time of the event occurred.

• Brand Name: E360 VENTILATOR
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): COVIDIEN; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer (Section G): COVIDIEN; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6048806
• MDR Text Key: 58505118
• Report Number: 8020893-2016-02802
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K053502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E360
• Device Catalogue Number: E360T-SY-IN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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