MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple attempts were made to retrieve repair and additional information however, no information has been provided by the customer.

Event Description

It was reported that an 840 ventilator with message as ac power loss with inoperative battery and compressor inoperative while in use on a patient.The patient was removed from the ventilator and placed on an alternate ventilator with adverse event as other serious(important medical events).

• 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: 6240595
• MDR Text Key: 64475754
• Report Number: 8020893-2017-00120
• 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
• Source Type: company representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/11/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR