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

Model Number	561CA
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Headache (1880); Eye Burn (2523)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop asthma.The patient required sinus surgery in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.A correction to b5 was made and should be: 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 reported an allegation of an issue related to a cpap device's sound abatement foam and became degraded and caused the patient to develop eyes burning, headache and asthma.The patient required sinus surgery in response to the reported event.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this follow-up will be filed.Section h6 health effect- clinical code was corrected (codes were missed to be captured in inital mdr), section h6 health impact code was corrected (incorrectly captured in initial report), section h6 type of investigation, investigation findings and investigation conclusions have been updated in this report.
Additional Manufacturer Narrative
Additional information was received on aug 29, 2024 and section h11 should be reported 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 previously reported an allegation of an issue related to a cpap device's sound abatement foam and became degraded and caused the patient to develop eyes burning, headache and asthma.The patient required sinus surgery in response to the reported event.The device was returned to the manufacturer's product investigation laboratory for investigation.During an external and internal inspection, the manufacturer observed that ui (users interface) knob missing.The air outlet port had dust-like contamination in it and air inlet had white dust-like contamination in it.Pca (printed circuit assembly) had dust-like contamination all over the top of it.Dust-like contamination on the top of the blower box lid and surrounding area and on the top of the blower motor and inside of the blower box.Bottom enclosure had 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 dust-like contamination on top of it.Evidence of sound abatement foam degradation/breakdown was not observed in this device.During an internal and external inspection of humidifier, the manufacturer observed that the potential corrosion in heated tube connector at iso port (international organization of standardization.) flip lid seal had unknown contamination on it and water chamber lid latch broken.Tan and white dust-like contamination, throughout humidifier enclosure.Unknown brown and tan dust-like contamination on and under the heater plate.Unknown white dust-like contamination on the dry box seals and in the iso port (international organization of standardization.).The contamination found in the humidifier enclosure are considered not to be in the airpath.The manufacturer was not able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes that there was no evidence of sound abatement foam degradation.The manufacturer confirmed that the source of contamination was external to the device.Sections b7, d9, h2, h3 and h6 has been updated in this report.

• Brand Name: REMSTAR AUTO A-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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12788336
• Report Number: 2518422-2021-06553
• Device Sequence Number: 17095839
• Product Code: BZD
• UDI-Device Identifier: 00606959030527
• UDI-Public: 00606959030527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 561CA
• Device Catalogue Number: 561CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 07/07/2023; 08/29/2024
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 09/06/2023; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2014
• 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
• Usage of Device: Unknown
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown