DREAMSTATION AUTO CPAP
Report
- Report Number
- 2518422-2024-06894
- Event Type
- Injury
- Date Received
- February 12, 2024
- Date of Event
- October 9, 2023
- Report Date
- September 9, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K131982
- Removal / Correction Number
- Z-1974-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
H3 OTHER TEXT : DEVICE NOT RETURNED.
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 ALLEGED RESPIRATORY TRACT IRRITATION, CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. MANUFACTURED INITIATED THERAPY WITH THE DEVICE AND VERIFIED AIRFLOW, USING A KNOWN GOOD PIL SUPPLIED POWER SUPPLY AND POWER CORD. EXTERNAL VISUAL INSPECTION FOUND NO EVIDENCE OF DAMAGE OR FAILURE. MANUFACTURED PERFORMED DREAM STATION MODEM EVALUATION PROCEDURE (16-700-211, VERSION 09) USING EFT 3100509-06 DREAM STATION MODEM ERROR LOG READER CONFIGURATION POD. DREAM STATION MODEM ERROR LOG READER SHOWED 0 ERRORS. MANUFACTURED PERFORMED ADDITIONAL TESTING AND VERIFIED THAT THE DREAM STATION BASE CPAP RECOGNIZES THE MODEM. THIS WAS DONE BY GOING TO THE MY SETUP MENU OF THE CPAP AND SCROLLING TO MODEM AND OBSERVING THAT IT SHOWS MODEM ON. AT MY PROVIDER MENU, PIL SCROLLED TO UPLOAD SCREEN AND TRIED TO MAKE A CALL. ERROR 1-0 WAS DISPLAYED INDICATING THAT IT SEES THE NETWORK BUT CANNOT HANDSHAKE TO IT. THE GREEN LIT BARS SHOWING SIGNAL STRENGTH WERE INDICATING THAT THE MODEM IS WORKING. DUST-LIKE CONTAMINATION AT THE AIR INLET OF THE BLOWER BOX. DUST-LIKE CONTAMINATION WAS ON TOP OF THE BLOWER MOTOR. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED. 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 DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WERE NO ERRORS FOUND. 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 ARE CONSISTENT WITH BEING FROM AN EXTERNAL SOURCE. BOX A: PATIENT IDENTIFIER (RFB) UPDATED. BOX B: ADVERSE EVENT/PRODUCT PROBLEM & OUTCOMES ATTRIBUTED TO AE UPDATED. BOX E: REPORTING INSTITUTION NAME, REPORTING ADDRESS LINE 1, REPORTING ADDRESS CITY UPDATED. BOX G: REPORT SOURCE (RFB) UPDATED. BOX H: DEVICE EVAL. BY MFG? (RFB), (DEVICE) PROBLEM CODE GRID, EVALUATION METHOD CODE, EVALUATION RESULTS CODE AND CONCLUSION CODE GRID HAS BEEN UPDATED. BOX D: DEVICE AVAIL. FOR EVAL? (RFB), DATE RETURNED (RFB) & DEVICE SERVICED BY 3RDP? UPDATED.
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 ALLEGED RESPIRATORY TRACT IRRITATION, 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377273 | DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX500T11C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |