MAUDE Adverse Event Report: COVIDIEN 740 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 740

Device Problems Defective Alarm (1014); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medtronic has received the suspect device/component from the customer for further evaluation.Upon completing the investigation, the results will be submitted within a supplemental mdr.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the 740 ventilator had a positive end expiratory pressure fault and failed to alarm.There was no patient involvement at the time of the event.

Manufacturer Narrative

(b)(4).Device evaluation summary: the medtronic field service engineer evaluated the ventilator and hoses relevant to the peep system were cleaned.All testing passed per manufacturer specifications.The ventilator was returned to the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

Originally it was reported that the 740 ventilator had a positive end expiratory pressure fault and failed to alarm.However, additional information was received confirmed that the ventilator actually did alarm.Both the visual and audible alarms were generated.

• Brand Name: 740 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway,gw
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 8773861
• MDR Text Key: 150557009
• Report Number: 8020893-2019-00136
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K990897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 740
• Device Catalogue Number: G-740220DIUR-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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