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

Model Number 840

Device Problem Communication or Transmission Problem (2896)

Patient Problems Premature Labor (2465); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that, an 840 ventilator had a loss of bd communication.The ventilator was not in use on a patient at the time the malfunction occurred.The service engineer (se) verified the malfunction and reported that the breath delivery unit (bdu) printed circuit board (pcb) needs to be replaced.

• 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: 6498057
• MDR Text Key: 72939638
• Report Number: 8020893-2017-05697
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521077133
• UDI-Public: 10884521077133
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• 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: 4-840220DIUA-EN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2017
• Date Device Manufactured: 04/16/2003
• 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