MAUDE Adverse Event Report: RESPIRONICS, INC GARBIN I; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1058180
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a failure of the ventilator's sensor board occurred.The device was not in patient use.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's sensor board was replaced to address the issue.

• Brand Name: GARBIN I
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 7269661
• Report Number: 2518422-2018-00368
• Device Sequence Number: 1847379
• Product Code: CBK
• UDI-Device Identifier: 00606959026483
• UDI-Public: 00606959026483
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: 1058180
• Device Catalogue Number: 1058180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1