MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTOA-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	IN561HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2022
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 no specific injury other than the patient suffered or might suffer in the future due to the device.The manufacturer was made aware of the complaint through a representative of the customer.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.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 : device not returned to manufacturer.
Additional Manufacturer Narrative
In this report 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.During the evaluation of the device at the third-party service center, the device was visually inspected and no visible foam particles were observed.Evalution found pca replaced.Error code was present.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.The following correction has been updated in this report.Section "product udi" in box d has been updated/corrected.Section "reporter country" in box e has been updated/corrected.Section "report source" in box g has been updated/corrected.Section "evaluation method code grid, evaluation results code grid, component code grid, conclusion code grid " in box h has ben updatd/corrected.

• Brand Name: REMSTAR AUTOA-FLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (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: 17857687
• Report Number: 2518422-2023-25208
• Device Sequence Number: 14970769
• Product Code: BZD
• UDI-Device Identifier: 00606959030763
• UDI-Public: (01)00606959030763
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: IN561HS
• Device Catalogue Number: IN561HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2015
• 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