MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	111P1160
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
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
Customer reported the tab/flap appeared to have been broken off on e-valve.The device was replaced.There was no patient injury or ill effects.
Additional Manufacturer Narrative
The sample was received for analysis and the reported issue was confirmed.The reported customer event is a known issue and root cause investigation efforts have been addressed in a corrective and preventative action.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DAR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• MDR Report Key: 7005232
• Report Number: 2936999-2017-05607
• Device Sequence Number: 19032574
• Product Code: CBK
• UDI-Device Identifier: 10884521100251
• UDI-Public: 10884521100251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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 Expiration Date: 07/01/2019
• Device Model Number: 111P1160
• Device Catalogue Number: 111P1160
• Device Lot Number: 140701330X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 02/20/2018
• 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