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

Model Number	1167P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
Event or Problem Description
The manufacturer received information alleging that a 67-year-old patient suffering from chronic obstructive pulmonary disease received a diagnosis of a lung mass following the use of a ventilator.It was reported that the mass in the lungs for the patient was ninety percent (90%) lung cancer and reached a size of three to five centimeters (3-5 cm).No additional clinical information or medical intervention has been specified at this time.The manufacturer's investigation is ongoing.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: 18140283
• Report Number: 2518422-2023-30221
• Device Sequence Number: 7991764
• Product Code: MNS
• UDI-Device Identifier: 00606959039261
• UDI-Public: 00606959039261
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: Other
• Device Model Number: 1167P
• Device Catalogue Number: 1167P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Unknown