MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 980

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The service engineer (se) evaluated the ventilator, and verified the customer reported malfunction.The se replaced the breath delivery power controller, printed circuit board assembly (pcba), to resolve the issue.

Event Description

It was reported that after a month of patient use, a ventilator was removed from a patient and placed in standby mode.The patient and device were then moved to a new location.During set-up in the new location, smoke was observed coming from the area around the exhalation filter and a burning smell was detected.The patient was transferred to another ventilator without harm.

Manufacturer Narrative

The device was repaired and the reported issue was isolated to interface between the device and the failed component.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 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 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5169946
• MDR Text Key: 29006581
• Report Number: 8020893-2015-01269
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2014
• 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