MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problems Erratic or Intermittent Display (1182); Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The service engineer (se) evaluated the ventilator, and verified the customer reported malfunction.The se replaced the graphical user interface (gui) printed circuit board (pcb) central processing unit (cpu) to resolve the issue.The unit passed all testing and calibrations, and was operating within the manufacturing specifications.

Event Description

It was reported that, the ventilator's lower display was changing colors red and blue, and generated multiple white horizontal lines.There is no information regarding patient involvement.

Manufacturer Narrative

(b)(4).The replaced graphical user interface (gui) printed circuit board (pcb) was returned for investigation.A visual inspection was conducted, and no anomalies were observed.The unit was attached to the failure investigation test ventilator for analysis, and it was powered.During power up, it was detected that the gui diagnostic led's was scanning from the center out and back to the center, indicating that the gui cpu was in the download mode, and there was no operating system software loaded on this board.The latest software version was successfully loaded.The ventilator was tested again, and passed power on self-test (post) without errors being recorded in the diagnostic logs tests and calibration were performed without any errors or alarms being generated.The test ventilator was set into ventilation mode for 312 hours without error or alarms.The customer reported malfunction was not verified.

Manufacturer Narrative

An investigation was performed and the technician found that the reported problem could not be duplicated.No failure was detected.If information is provided in the future, a supplemental report will be issued.

• 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: thom mcnamara ; 15 hamsphire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5448785
• MDR Text Key: 39022778
• Report Number: 8020893-2016-00395
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2017

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: 4-840120DIUU-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided; 03/14/2016
• Supplement Dates FDA Received: 03/15/2016; 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2002
• 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