MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 980

Device Problems Device Emits Odor (1425); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The field service engineer (fse) evaluated the ventilator and verified the reported malfunction.The fse replaced the power supply printed circuit board (pcb).The device then passed all testing.

Event Description

It was reported that during patient use, a ventilator generated an electrical smoking smell and became inoperative.The patient was transferred to another ventilator without harm.

Manufacturer Narrative

The suspect component was returned to covidien/ medtronic¿s product analysis. a visual inspection of the returned component was performed.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported 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: 980 VENTILATOR
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): COVIDIEN; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer (Section G): GALWAY (RC)-RX; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5136134
• MDR Text Key: 27812522
• Report Number: 8020893-2015-01126
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: 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?: 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: 03/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: 09/14/2015
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2014
• 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