FDA Adverse Event
Malfunction
Summary report: N
DENTAL OPERATING CHAIR
MDR report key: 33823
·
Received June 28, 1996
Report
- Report Number
- MW4001378
- Event Type
- Malfunction
- Date Received
- June 28, 1996
- Report Date
- August 31, 1995
- Manufacturer
- STAR DENTAL PRODUCTS, INC.
- Product Code
- KLC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FOOT CONTROL UNITS ON THE DENTAL CHAIR ARE EXTREMELY FRAGILE AND SUBJECT TO DAMAGE EASILY. THE TYPES OF DAMAGE INCLUDE BROKEN BUTTONS, SWITCHES, CRACKED CASES AND CONNECTING CORDS PULLING OUT OF THE STRAIN RELIEF. THE UNUSUALLY HIGH LEVEL OF OCCURRENCES HAS AT TIMES RENDERED AS MANY AS 25% OF THE UNITS IN ONE CLINIC UNUSABLE. THE AMOUNT OF TIME TO OBTAIN REPLACEMENT WARRANTY PARTS FROM THE MFR IN MOST CASES HAS EXCEEDED 30 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DENTAL OPERATING CHAIR | DENTAL OPERATING CHAIR | KLC | STAR DENTAL PRODUCTS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |