FDA Adverse Event
Malfunction
Summary report: N
REMSTAR AUTO A-FLEX
MDR report key: 24035635
·
Received January 12, 2026
Report
- Report Number
- 2518422-2025-113230
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- December 18, 2025
- Report Date
- March 19, 2026
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K091319
- Removal / Correction Number
- Z-1974-2021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
510K HAS BEEN UPDATED TO K091319.
Description of Event or Problem · 0
THE REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, IT WAS VISUALLY INSPECTED, AND THE ENGINEER FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION, DUST FAIL CONTAMINATION AND DISPLAYED ERROR CODE: 24 (E-24: ERR_MOTOR_SPEED_REVERSE), ERROR CODE: 30 (E-30: ERR_MOTOR_SPINUP_FLUX_HIGH). THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98585 | REMSTAR AUTO A-FLEX | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | CA551HS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |