MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the service engineer (se) inspected the device and verified the reported issue.The se ran an extended self test (est) and the breath delivery unit (bdu) audio test failed with the power fail cap not discharging.The se replaced the exhalation sensor printed circuit board (pcb) and the power controller pcb.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a 980 ventilator failed an extended self test (est) and generated error codes with the messages: "power-fail cap not discharging" and "exp pressure autozero offset failed." the ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Evaluation summary: the following components were returned for failure investigation: 1.Exhalation sensor printed circuit board (pcb) 2.Breath delivery (bd) printed circuit board assembly (pcba) the bd pcba was visually inspected and functionally tested with no malfunction or product deficiency identified.Upon receipt a visual inspection of the exhalation sensor, it was noted that there was severe damage on the pcb.Due to such extensive damage the pcb was unable to be inserted into the exhalation valve assembly.It is unknown and unreported how this damage occurred.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• MDR Report Key: 7797579
• Report Number: 8020893-2018-00381
• Device Sequence Number: 10793172
• Product Code: CBK
• UDI-Device Identifier: 10884521171749
• UDI-Public: 10884521171749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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
• Operator of Device: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980X1ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1