FDA Adverse Event
Malfunction
Summary report: N
VALIDATOR PLUS STERILIZER
MDR report key: 34620
·
Received July 25, 1996
Report
- Report Number
- MW4001418
- Event Type
- Malfunction
- Date Received
- July 25, 1996
- Report Date
- July 17, 1996
- Manufacturer
- PELTON & CRANE CO.
- Product Code
- FLE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVERY SIX MONTHS THE DEVICE'S FUSE BLOWS AND ITS COMPARTMENT MELTS. RPTR HAD IT SERVICED SEVERAL TIMES. THE MFR WAS CONTACTED AND TOLD HIM THEY HAD DESIGNED THE DEVICE TO DO EXACTLY WHAT HE HAD BEEN COMPLAINING ABOUT. THEY WOULD NOT GIVE A REASON FOR IT. RPTR FEELS THESE INCIDENTS COULD CAUSE A FIRE IN HIS OFFICE. RPTR FEELS THAT THE MFG FIRM IS VERY UNCOOPERATIVE IN RESOLVING THE PROBLEM, OR DOING ANYTHING TO CORRECT THE MALFUNCTIONING OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALIDATOR PLUS STERILIZER | INSTRUMENT STERILIZER | FLE | PELTON & CRANE CO. | AC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |