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

Model Number	CA261NTS
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Unspecified Respiratory Problem (4464); Solid Tumour (4552)
Date of Event	01/13/2022
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 a bladder tumor.The patient required 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 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 allegation issue related to a cpap device's sound abatement foam.Patient alleged to develop a bladder tumor.The patient required surgery in response to the reported event.There was no report of patient harm or injury.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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 updated in this report.Section h6 codes has been updated as a correction for previous report.
Additional Manufacturer Narrative
Additional information was received on sep 06, 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 received information allegation issue related to a cpap device's sound abatement foam.Patient alleged to develop a bladder tumour, hard of breathing, raspiness in lungs and respiratory issues.The patient required surgery in response to the reported bladder tumour.The device was returned to the manufacturer's product investigation laboratory for investigation.During the external and internal inspection, the manufacturer observed ui (users interface) knob missing.The air outlet port had dust-like contamination in it.Air inlet had white dust-like contamination in it.Pca (printed circuit assembly) had light dust-like contamination all over the top of it.Dust-like contamination on the top of the blower box lid and surrounding area and also on the top of the blower motor and inside of the blower box and bottom enclosure.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 internal and external inspection of humidifier, the manufacturer observed dust-like contamination on flip lid seal, water chamber missing.Tan and white dust-like contamination, throughout humidifier enclosure.Unknown tan dust-like contamination on and under the heater plate.Unknown white dust-like contamination on the dry box seals.Unknown white and brown dust-like contamination 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 the source of contamination was external to the device.The manufacturer was missed to capture respiratory issues in previous report, which was corrected in this report.

• Brand Name: REMSTAR PLUS
• 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: 13314456
• Report Number: 2518422-2022-01421
• Device Sequence Number: 14618528
• Product Code: BZD
• UDI-Device Identifier: 00606959030084
• UDI-Public: 00606959030084
• 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,Consumer
• 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: CA261NTS
• Device Catalogue Number: CA261NTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 02/21/2023; 09/06/2024
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 04/13/2023; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2012
• 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