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

Model Number	980
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during use on a patient, the upper screen on a 980 ventilator went blank.The ventilator continued to ventilate the patient, and later, the blank screen reoccurred.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.The service engineer (se) inspected the device and found a diagnostic code in the memory logs, however, the repair of the device has not been completed.
Additional Manufacturer Narrative
Additional information was received on 2017-may-11 regarding ventilator repair status.Device evaluation: the 980 ventilator without the battery was returned to medtronic¿s failure analysis laboratory.A visual inspection of the ventilator was performed and no anomalies were found.An investigation was performed and the reported issue was not duplicated.No fault was found with the returned ventilator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, during use on a patient, the upper screen on a 980 ventilator went blank.The ventilator continued to ventilate the patient, and later, the blank screen reoccurred.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.The service engineer (se) inspected the device and found a diagnostic code in the memory logs.The ventilator was removed from service and replaced by a new ventilator.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6542023
• Report Number: 8020893-2017-05952
• Device Sequence Number: 864933
• Product Code: CBK
• UDI-Device Identifier: 10884521171749
• UDI-Public: 10884521171749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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
• 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: 05/29/2017
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention