PRI Cellular Modem PRI Cellular Modem, USRecalls & reported problems
Respironics, Inc. · PRI Cellular Modem, USA · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959026674), received between Mar 27, 2024 and Nov 7, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Degraded” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded3
- Contamination1
Patient problems
- Cancer2
- Respiratory Tract Infection2
- Asthma1
- Heart Failure/Congestive Heart Failure1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2025Contamination; Degraded; Contamination; Degraded
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 INTEGRI
Patient problems: Cancer
MAUDE report 23494606 ↗InjuryApr 10, 2024Degraded; Degraded
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 AN ACCESSORY (PRI CELLULAR MODEM) OF AN UNKNOWN SYSTEM ONE DEVICE AFFECTED BY THE RECALL. THE PATIENT ALLEGED HEART FAILURE. IN ADDITION, THE PATIENT ALSO REPORTED NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, CHRONIC ASTHMA, AND ASPERGILLUS. MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE PATIENT. DUE TO POTENTIAL LITIGATION SURROUNDING THIS CASE, NO FOLLOW UP CAN BE PERFORMED AT THIS TIME. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: Asthma; Heart Failure/Congestive Heart Failure; Respiratory Tract Infection
MAUDE report 19077789 ↗InjuryMar 27, 2024Degraded; Degraded
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 PRI CELLULAR MODEM DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED RESPIRATORY TRACT IRRITATION AND CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Cancer; Respiratory Tract Infection
MAUDE report 18989953 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.