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

Model Number	1058180B
Medical Device Problem Codes	No Audible Alarm (1019); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/18/2018
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a ventilator failed to alarm when a patient became disconnected from the ventilator.The manufacturer's investigation is currently on-going and a follow-up report will be filed when the investigation is complete.
Additional Manufacturer Narrative
It was initially reported the manufacturer received information alleging a ventilator failed to alarm when a patient became disconnected from the device.The patient expired.The ventilator was returned to the manufacturer for evaluation.The device passed all testing and was found to operate and alarm as designed.The ventilator's downloaded event logs were reviewed.The device maintains the event logs in non-volatile memory.An event, as logged by the device, includes every keypress, alarm or failure of the device to remain within specifications.There were no events logged related to device performance or device malfunctions.If a device malfunction occurred, the event logs would have contained entries related to the malfunction.Patient data logs were also downloaded from the ventilator.

• Brand Name: GARBIN VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 7781731
• Report Number: 2518422-2018-01922
• Device Sequence Number: 19281156
• 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,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1058180B
• Device Catalogue Number: 1058180B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 11/06/2018
• 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: Death