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

Model Number	980
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 980 ventilator generated an error message.Although requested, it is unknown if the patient was connected to the ventilator at the time of the reported event.The service engineer (se) inspected the device and found diagnostic codes in the ventilators memory logs.The se installed a new version of software.The se performed calibrations and extended self-testing on the device and all tests passed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The reported issue occurred during routine service and repair.The ventilator was not on a patient at the time of the event.

• Brand Name: PURITAN BENNETT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6634976
• Report Number: 8020893-2017-06528
• Device Sequence Number: 6522
• Product Code: CBK
• UDI-Device Identifier: 10884521172593
• UDI-Public: 10884521172593
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2017

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: 05/16/2017
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1