MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 980

Device Problems Device Emits Odor (1425); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a exhibition, the ventilator generated an alarm and stopped cycling.A burning smell was confirmed and the device was turned off.There was no reported patient involvement associated with this event.

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 issue was verified.The identified root cause of 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: 5138953
• MDR Text Key: 28185651
• Report Number: 8020893-2015-01086
• 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: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980
• Device Catalogue Number: PB980-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: 09/09/2015
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1