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

Model Number	DE962S
Medical Device Problem Codes	Degraded (1153); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Cough (4457)
Date of Event	03/22/2024
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.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.A device was returned to the manufacturer for evaluation to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device, the third-party service center visually inspected the device and has no visualization of foam particles.In addition to above findings, there was a present of contamination in the device, which is dust/dirt.There was also a present of error code, which is #32.The device was routed to scrap.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
This report is being sent to correct the report previously filed.The manufacturer received an allegation of persistent cough and chest pressure sensation when using a cpap device.Information was received that the device was already returned for evaluation.No medical intervention was reported nor any serious harm or injury.During the evaluation of the device, the service center visually inspected the device and found no visualization of foam particles.The evaluation did find contamination of dust/dirt in the device as well as an error code 32 which is a technical error designed to alert the user that the pressure support is half the set point for at least 60 seconds.The device will continue to operate without noticeable alteration.There is no evidence that the device malfunctioned in a manner that would be likely to cause or contribute to death or serious injury if it were to recur.There is no allegation of serious or permanent harm or injury.There was no report of medical intervention.This complaint was incorrectly reported previously and is not reportable to any regulatory agencies.

• Brand Name: BIPAP AUTOSV ADV
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19988869
• Report Number: 2518422-2024-51573
• Device Sequence Number: 8432838
• Product Code: MNS
• UDI-Device Identifier: 00606959029682
• UDI-Public: (01)00606959029682
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: DE962S
• Device Catalogue Number: DE962S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2017
• 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
• 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