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

Model Number	DS1160S
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
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 visualization of particles in the air path.The patient is also alleging that the device will not turn on and the device is not functioning, as well as other unspecified thermal issues.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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 information 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.Additional information received from the patient indicates there is no allegation of particles or residue in the device.Section h6 device problem code, there was no allegation of degradation.The device has not yet been returned to the manufacturer for evaluation.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
Additional information was received and the section h11 should be update as, 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.The patient is also alleging that the device will not turn on and the device is not functioning, as well as other unspecified thermal issues.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer inspected externally and internally, investigation found missing air inlet filter, missing sd card cover, cosmetic mark on lcd display, dent on ui (users interface) panel at lcd window, the air outlet port had dust-like contamination in it.Air inlet had white dust-like contamination in it.Pca (printed circuit assembly) had light dust-like contamination all over the top of it.Light dust-like contamination on the top of the blower box lid and surrounding area.Light dust-like contamination on the top of the blower motor light dust-like contamination inside of the blower box.Bottom enclosure had light dust-like contamination in it.Air inlet seal had yellowed and had dust-like contamination on it.The sound abatement foam was intact and had light dust-like contamination on top of it.Evidence of sound abatement foam degradation/breakdown was not observed in this device.The source of contamination was most likely external to the device.The manufacturer found 289 error codes.Pil was unable to address the complaint of device will not turn on/device not functioning but could confirm particles in airway from device.Section d,g,h has been updated.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 16685957
• Report Number: 2518422-2023-08230
• Device Sequence Number: 7967517
• Product Code: MNS
• UDI-Device Identifier: 00606959012578
• UDI-Public: 00606959012578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2025

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: DS1160S
• Device Catalogue Number: DS1160S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 10/30/2024
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/05/2023; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2014
• 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: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown