MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO A-FLEX; VENTILATOR NON-CONTINIOUS (RESPIRATOR)

Model Number	DE562S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dizziness (2194); Cough (4457)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device has not been yet returned to the manufacturer.
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 an issue related to a remstar autoa-flex device's sound abatement foam.The patient has alleged coughing and occasional dizziness.There was no report of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for investigation.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 received information alleging an issue related to a dreamstation cpap pro device's sound abatement foam.The patient has alleged nose bleeds.There was no report of serious or permanent harm or injury.No medical intervention was reported by the patient.Despite multiple attempts by email to '(b)(6)' on 11/23/2023, 11/30/2023 and 12/06/2023, the device has not yet returned to the manufacturer for evaluation.There has been no response from the customer on the return of the device.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
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 previously received information alleging an issue related to a remstar auto a-flex device's sound abatement foam.The patient has alleged coughing and occasional dizziness.The device was returned to the third-party service center for further evaluation.During the evaluation of the device at the third-party service centre, the device was visually inspected and found no evidence of foam degradation.During the evaluation, no secondary findings was observed.The device powered on, and airflow was confirmed.The device's downloaded logs were reviewed by the third-party service centre.There was no error code found the third-party service center concludes that they couldn't confirm the customer's allegation and there was no visible foam degradation and unit got scrapped.Sections h6 has been updated in this report.Section e1 has been updated in this report, previously captured wrong.(previous report it was reporter country-australia).

• Brand Name: REMSTAR AUTO A-FLEX
• Common Device Name: VENTILATOR NON-CONTINIOUS (RESPIRATOR)
• 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: 18048049
• Report Number: 2518422-2023-28448
• Device Sequence Number: 12619221
• Product Code: BZD
• UDI-Device Identifier: 00606959024083
• UDI-Public: (01)00606959024083
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2025

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: DE562S
• Device Catalogue Number: DE562S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/06/2023; 09/27/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 08/22/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2015
• 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-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown