MAUDE Adverse Event Report: RESPIRONICS, INC. MICRO-FLEXIBLE HEATED 12MM TUBE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	HT12
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the device had an odor that smelled like fire smoke.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
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging the device had an odor that smelled like fire smoke.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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.If pertinent information becomes available to the manufacturer at a later date, an addendum to this report will be filed.
Additional Manufacturer Narrative
In the previous report the manufacturer received information alleging the device had an odor that smelled like fire smoke.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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.If pertinent information becomes available to the manufacturer at a later date, an addendum to this report will be filed.This report is filed to report that no additional information can be received at this time.
Additional Manufacturer Narrative
Repair evaluation information was received on 11/28/2023 and section h11 should be reported as: the manufacturer received information alleging the device had an odor that smelled like fire smoke.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 received the micro-flexible heated 12mm tube and found it was damage and defect free and still in a normal design orientation as intended.The tubing was passed around to different pil techs for evaluation.No pil tech could detect any fire smell.Pil mated the tubing to a pil dreamstation 2 and then to a quick lung.The tubing connects to the dreamstation 2 securely and will not disconnect until the release tabs are engaged.Pil applied power and verified the base unit does recognize the heated tubing, no error messages occurred.Pil used a thermal imager and measured the ambient temperature of the tubing which was 21°c, then pil applied power and observed after approximately five minutes the temperature of the tubing had risen to 28°c indicating that the tubing was functioning as designed.This test was run overnight, approximately 14 hours.No types of smells were observed.The tubing temperature was still at 28°c.The manufacturer used a fitt (foam integrity test tool) and 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 there was no evidence of sound abatement foam degradation and there is no visible damage or functionality failures of the device.The manufacturer observed dust contamination and water marks in the device and are consistent with being from an external source.

• Brand Name: MICRO-FLEXIBLE HEATED 12MM TUBE
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17849187
• Report Number: 2518422-2023-25089
• Device Sequence Number: 7173524
• Product Code: BZD
• UDI-Device Identifier: 00606959417540
• UDI-Public: 00606959417540
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2025

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: HT12
• Device Catalogue Number: HT12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 11/28/2023
• Initial Report FDA Received Date: 09/30/2023
• Supplement Report FDA Received Date: 11/20/2023; 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Female