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

Model Number	IN1161S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging that the patient has stopped using the device after the release of the fsn.He is concerned about the health risks.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.Due to no device information being provided, the exact recall number is unknown.The possible recall numbers are z-1972-2021, z-1973-2021, and z-1974-2021.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : the device has not been returned to the manufacturer.
Additional Manufacturer Narrative
The manufacturer was previously contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging that the patient has stopped using the device after the release of the fsn.He is concerned about the health risks.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.In this report- box d: suspect medical device-product brand name, fda product code, common device name, model number (rfb), catalog item identifier (rfb), serial number (rfb), product udi (rfb) and 510k and recall (z) number (rfb) has been updated/corrected.

• Brand Name: BIPAP AVAPS C SERIES, INTERNATIONAL
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17902520
• Report Number: 2518422-2023-26085
• Device Sequence Number: 15343759
• Product Code: MNS
• UDI-Device Identifier: 00606959022034
• UDI-Public: (01)00606959022034
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: IN1161S
• Device Catalogue Number: IN1161S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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