MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP V30 AUTO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1111178
Medical Device Problem Codes	Degraded (1153); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The clinical assessment states that based on the information currently provided and available, no harm or injury has been sustained and therefore further analysis of cause and/or contribution of the device to a serious injury or death is not applicable.The reporter notes pre-existing conditions of: respiratory failure, copd/asthma or other chronic lung disease, history of myocardial infarction or cardiac arrest, congestive heart failure, chronic oxygen dependency.Based upon the information provided, these conditions have been reviewed and assessed as unrelated to the device.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported 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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The clinical assessment states that based on the information currently provided and available, no harm or injury has been sustained and therefore further analysis of cause and/or contribution of the device to a serious injury or death is not applicable.The reporter notes pre-existing conditions of: respiratory failure, copd/asthma or other chronic lung disease, history of myocardial infarction or cardiac arrest, congestive heart failure, chronic oxygen dependency.Based upon the information provided, these conditions have been reviewed and assessed as unrelated to the device.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Additionally, a customer response update was received stating that upon further information, there were no particles found.This device and complaint should no longer be included in the recall.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: BIPAP V30 AUTO
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20546107
• Report Number: 2518422-2024-102725
• Device Sequence Number: 18111177
• Product Code: MNS
• UDI-Device Identifier: 00606959067936
• UDI-Public: (01)00606959067936
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: 1111178
• Device Catalogue Number: 1111178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2020
• 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-1957-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown