MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AVAPS C-SERIES; VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING

Model Number	IT1161S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Skin Inflammation/ Irritation (4545)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned for evaluation.
Event or Problem Description
The manufacturer became aware of a user of a bipap avaps c series device was experiencing headaches and skin irritation, especially of the head since (b)(6) 2021.There was no report of visible particles seen of any kind.The device is currently at the patient's home.The product has not been returned for investigation.The manufacturer's investigation is on-going.A follow up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP AVAPS C-SERIES
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING
• 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 15208 ; 4125423300
• MDR Report Key: 17908724
• Report Number: 2518422-2023-26200
• Device Sequence Number: 7701023
• Product Code: MNS
• UDI-Device Identifier: 00606959048171
• UDI-Public: 00606959048171
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: IT1161S
• Device Catalogue Number: IT1161S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown