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

Model Number	980
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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 the power on self-test (post) and generated a diagnostic error message.The ventilator was not in use on a patient at the time of the reported event.The service engineer (se) inspected the device, replaced the breath delivery (bd) central processing unit (cpu) printed circuit board (pcb), and installed software.The se performed calibrations and extended self-testing on the device and all tests passed.
Additional Manufacturer Narrative
Failure investigation: investigation: the breath deliver (bd) printed circuit board (pcb) was returned for failure investigation.The part was visually inspected with no anomalies observed.The pcb was attached to the failure investigation test ventilator for analysis.The unit was placed in ventilation mode for a minimum of 24 hours with no alarms or errors observed.Conclusion: the reported event could not be replicated.There was no fault found.There was no malfunction or product deficiency identified.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; micheal collins rd mervue; galway
• MDR Report Key: 6730445
• Report Number: 8020893-2017-07043
• Device Sequence Number: 19175282
• Product Code: CBK
• UDI-Device Identifier: 10884521171732
• UDI-Public: 10884521171732
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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
• Operator of Device: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1