REP DREAMSTATION AVAPS30
Report
- Report Number
- 2518422-2025-001813
- Event Type
- Injury
- Date Received
- January 10, 2025
- Date of Event
- June 6, 2024
- Report Date
- July 23, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNS
- UDI-DI
- 00606959063457
- PMA / PMN Number
- K102465
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
IN THIS REPORT SECTION ADVERSE EVENT/PRODUCT PROBLEM, TYPE OF REPORTED COMPLAINT, HEALTH IMPACT GRID HAS BEEN UPDATED/CORRECTED.
THE MANUFACTURER RECEIVED INFORMATION PATENT PASSED AWAY. THERE WAS REPORT OF SERIOUS OR PERMANENT 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. BOX H: EVALUATION METHOD CODE, EVALUATION RESULTS CODE AND CONCLUSION CODE GRID HAS BEEN UPDATED.
THE MANUFACTURER RECEIVED INFORMATION PATENT PASSED AWAY. THERE WAS REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURE FOR EVALUATION. 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 |
|---|---|---|---|---|---|---|---|
| 511583 | REP DREAMSTATION AVAPS30 | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | MNS | RESPIRONICS, INC. | DSX1130S11F | 00606959063457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| O |