MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 980

Device Problems No Display/Image (1183); Device Emits Odor (1425); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The covidien service engineer (se) inspected the device and verified the reported issue.The se replaced the direct current (dc) to dc converter printed circuit board (pcb), primary and secondary batteries, battery backplane pcb, and the breath delivery controller distribution pcb.The se performed extended self-testing on the device and all tests passed.

Event Description

It was reported that, a 980 ventilator was inoperable with no visible displays and had a burning smell.The ventilator was not in use on a patient at the time the event occurred.

Manufacturer Narrative

Product analysis: batteries, breath delivery (bd) distribution printed circuit board (pcb), bd power controller pcb, direct current (dc) to dc converter pcb and battery backplane were returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned components was performed, no notable conditions were found on the batteries and bd power controller pcb.Thermal damage was found on components on the bd distribution pcb (r6 resistor) and the dc to dc pcb (c56).The returned components were installed into a test ventilator for analysis; no errors were recorded in the diagnostic logs.An investigation was performed and the product analysis technician reported that the root cause for the batteries was isolate to a short circuit in the battery.The bd distribution pcb was isolated to the component (r6) in the pcb.No fault was found on the bd power controller pcb and battery backplane.The dc to dc converter pcb root cause was isolated to the thermal damaged, however the origin could not be determined.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: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 5960861
• MDR Text Key: 55331757
• Report Number: 8020893-2016-02429
• 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: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• 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: 980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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