MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 840

Device Problem Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, an 840 vent had a severe occlusion alarm.The ventilator was not in use on a patient at the time the event occurred.The covidien service engineer (se) verified the issue.The se inspected the device and replaced the analog interface (ai) printed circuit board (pcb).The unit passed all testing and operated within the manufactures specifications.

Manufacturer Narrative

Evaluation: the analog interface (ai) printed circuit board (pcb) was returned to medtronic¿s product analysis laboratory.A visual inspection was performed and no anomalies were observed.An investigation was performed and the reported issue was not duplicated.No errors were recorded in the diagnostic logs during testing.No fault was found with the returned ai pcb.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: 6747489
• MDR Text Key: 81183970
• Report Number: 8020893-2017-07134
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521077034
• UDI-Public: 10884521077034
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

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: 840
• Device Catalogue Number: 4-840220DIEC-IT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2001
• 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