MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problems Sticking (1597); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported that a member of their staff tried to perform extended self-testing (est) and did not complete the process.The customer reported to have performed est and all tests passed.Covidien was not authorized to repair the device.

Event Description

It was reported that, the safety valve on an 840 ventilator was stuck in and the ventilator went into an inoperable state.The ventilator was not in use on a patient at the time the event occurred.

• Brand Name: 840 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: 6150947
• MDR Text Key: 62137788
• Report Number: 8020893-2016-03356
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2016

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: 4-840120DIUU-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2003
• 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