DREAMSTATION
Report
- Report Number
- 2518422-2025-101147
- Event Type
- Malfunction
- Date Received
- January 23, 2025
- Date of Event
- January 8, 2025
- Report Date
- December 2, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K131982
- Removal / Correction Number
- Z-1974-2021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER/MANUFACTURER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED. UPON REVIEW, IT WAS DETERMINED THIS REPORT IS A DUPLICATE OF MFR 2518422-2025-027037. ALL REPORTING WILL BE COMPLETED ON MFR 2518422-2025-027037. PLEASE DISREGARD MFR 2518422-2025-101147.
A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER/MANUFACTURER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662341 | DREAMSTATION | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX500T11C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |