MAUDE Adverse Event Report: RESPIRONICS, INC. PRI CELLULAR MODEM; MEDICAL DEVICE DATA SYSTEM

Model Number	100204C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
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 an issue related to a cpap device's sound abatement foam.The patient has alleging water tank, and filter with the complaint of lung cancer.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed an external wear and tear, multiple contaminants on exterior of base unit.Broken ui knob.Excessive mineral deposits and other contaminants on the interior of humidifier water tank enclosure.0 errors logged, 6,159.6 blower and 6,159.2 therapy hours were logged.Care orchestrator data shows the patient had a compliance rate of 4.4% and used the humidifier at various settings during the most recent 90 days of use.Dust contamination observed throughout the airpath, on/in blower, and on sound abatement foam.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 zero error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes, there was no evidence of sound abatement foam degradation/breakdown and observed multiple contaminants and was not able to confirm the complaint or address the symptoms specified.

• Brand Name: PRI CELLULAR MODEM
• Common Device Name: MEDICAL DEVICE DATA SYSTEM
• 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: 23494606
• Report Number: 2518422-2025-051548
• Device Sequence Number: 8904375
• Product Code: OUG
• UDI-Device Identifier: 00606959026674
• UDI-Public: (01)00606959026674
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: 100204C
• Device Catalogue Number: 100204C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown