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

Model Number	1134711
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator was alarming for a flow sensor error.There was no harm or injury reported.The external flow sensor was replaced to address the issue.The external flow sensor was returned to the manufacturer for evaluation.The external flow sensor was contaminated with dust and dirt.

• Brand Name: Sensor
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206
• MDR Report Key: 13054094
• Report Number: 2518422-2021-08449
• Device Sequence Number: 16546427
• Product Code: CBK
• UDI-Device Identifier: 00606959050839
• UDI-Public: 00606959050839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: 1134711
• Device Catalogue Number: 1134711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown