FDA Adverse Event
Malfunction
Summary report: N
BELIMED STEAM STERILIZER MST-H TOP 5000
MDR report key: 11712824
·
Received April 23, 2021
Report
- Report Number
- 3001061128-2021-00008
- Event Type
- Malfunction
- Date Received
- April 23, 2021
- Date of Event
- August 6, 2019
- Report Date
- April 22, 2021
- Manufacturer
- BELIMED AG
- Product Code
- FLE
- PMA / PMN Number
- K170228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH THE PREVACUUM CYCLE WAS INITIALLY MISLABELED AS GRAVITY ON (B)(6) 2019, A SINGLE RUN OF THE INCORRECTLY LABELED CYCLE WAS CARRIED OUT FOR VERIFICATION PURPOSES AND THE ERROR WAS DETECTED. THE NAME OF THE PROGRAM WAS CORRECTED ON 8/14/ 2019, BEFORE THE PROGRAM WAS INCORPORATED INTO ROUTINE USE AT THE HEALTHCARE FACILITY. IT IS RUNNING PROPERLY.
Description of Event or Problem · 1
ON (B)(6) 2019, A PREVACUUM STERILIZATION CYCLE WAS PROGRAMMED ON A STERILIZER, BUT INCORRECTLY LABELED AS A GRAVITY CYCLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615008 | BELIMED STEAM STERILIZER MST-H TOP 5000 | STEAM STERILIZER | FLE | BELIMED AG | GR 9-6-15 HS2 | 24212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |