FDA Adverse Event
Malfunction
Summary report: N
16" EAGLE 2000 GRAVITY STERILIZER
MDR report key: 490412
·
Received October 10, 2003
Report
- Report Number
- 2515984-2003-00001
- Event Type
- Malfunction
- Date Received
- October 10, 2003
- Date of Event
- September 10, 2003
- Report Date
- September 10, 2003
- Manufacturer
- STERIS CORPORATION - ERIE
- Product Code
- FLE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
UNIT WAS ON BUT NOT HEATING. MAINTENANCE FOUND THE THREE PHASE BREAKER WAS TRIPPED. WHEN THE MAINTENANCE RESET IT THE OPERATOR WENT TO SET THE SWITCH FROM 'STANDBY TO 'ON'. AT THIS TIME THE OPERATOR FELT A SHOCK AND WITNESSED A BRIGHT NOISY FLASH. THE OPERATOR GOT A TINGLE IN THEIR FINGERS WHICH CAUSED THEM TO TOUCH THE COUNTERTOP BEHIND. STERIS TECHNICIAN FOUND THE HEATER COIL WAS BURNT OUT AND THE GROUND WIRE FROM THE CHASSIS TO HEATER PLATE WAS BURNT AND CONTRACTOR POINTS BLACKENED. TECH REPLACED HEATER ASSY AND CONTACTOR AND REPAIRED GROUND WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 16" EAGLE 2000 GRAVITY STERILIZER | STEAM STERILIZER | FLE | STERIS CORPORATION - ERIE | 2011 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |