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

Model Number 1167P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cancer (3262)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event 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
• Type of Device: 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
• MDR Text Key: 328170836
• Report Number: 2518422-2023-30221
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959039261
• UDI-Public: 00606959039261
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• 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
• Device Operator: Other
• Device Model Number: 1167P
• Device Catalogue Number: 1167P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR