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

Model Number	561CA
Medical Device Problem Codes	Degraded (1153); Device Emits Odor (1425)
Health Effect - Clinical Codes	Cough (4457); Unspecified Respiratory Problem (4464)
Date of Event	02/06/2025
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 a remstar auto a-flex device emitted a plastic odor off and on for a long-time during use and the patient wakes up with congestion and a cough.The patient was prescribed a puffer to use when needed.The patient cleans the device once a week with warm water and soap.The patient was angry that no one notified her of the recall, and she did not want to pay for another device.There was no report of serious patient harm or injury.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 was previously 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 a remstar auto a-flex device emitted a plastic odor off and on for a long-time during use and the patient wakes up with congestion and a cough.The patient was prescribed a puffer to use when needed.The patient cleans the device once a week with warm water and soap.The patient was angry that no one notified her of the recall, and she did not want to pay for another device.There was no report of serious patient harm or injury.The device was returned to the manufacturer for investigation.The product investigation lab received the device with the humidifier.No sd card was returned.No other peripherals or accessories were returned with the device.During the evaluation of the device, the product investigation lab visually inspected the device and did not observe any evidence of sound abatement foam degradation or breakdown.The product investigation lab initiated therapy with the device and verified airflow, using a known good, supplied power supply and ac power cord.The product investigation lab also observed the customers humidifier heater plate did heat.The product investigation lab used a lab supplied heated tube on the customer¿s humidifier and observed the tube did heat.The product investigation lab observed the following from and external and internal inspection: the ui (user interface) knob was broken.The air outlet port had dust-like contamination in it.The air inlet had white dust-like contamination in it.The pca (printed circuit assembly) had dust-like contamination all over the top of it.There was a thermal event on the humidifier harness connector and pca at j9.An intermetallic growth issue caused thermal damage to the j9 connector.There was dust-like contamination on the top of the blower box lid and surrounding area.There was dust-like contamination on the top of the blower motor and inside of the blower box.The bottom enclosure had dust-like contamination in it.The 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.There is no visible damage or functionality failures of the device, which suggests that the source of contamination was most likely external to the device.The product investigation lab observed the following from an internal and external inspection of the humidifier: the flip lid seal had unknown dust-like contamination on it.There was white dust-like contamination, throughout humidifier enclosure.There was unknown white dust-like contamination on and under the heater plate.There was unknown white dust-like contamination on the dry box seals.There was unknown white and tan dust-like contamination in the iso port (international organization of standardization).There was light dust-like contamination inside water tank.The contamination found in the humidifier enclosure is considered not to be in the airpath.The source of contamination was most likely external to the device.The product investigation lab was unable to obtain care orchestrator information from the device.The product investigation lab was unable to address the specified symptoms.Review of the device log showed: error logged: 32 errors were logged.No actionable errors were identified in the log files.The device was likely reset prior to receipt as indicated by the device having 38,411.6 machine hours and no blower or therapy hours.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

• Brand Name: REMSTAR AUTO A-FLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 21343081
• Report Number: 2518422-2025-101877
• Device Sequence Number: 7835984
• Product Code: BZD
• UDI-Device Identifier: 00606959030527
• UDI-Public: (01)00606959030527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 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: 02/06/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2015
• 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
• Usage of Device: Reuse
• 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 Age: 67 YR
• Patient Sex: Female