FDA Adverse Event
Malfunction
Summary report: N
ZEISS
MDR report key: 197647
·
Received November 16, 1998
Report
- Report Number
- MW1014978
- Event Type
- Malfunction
- Date Received
- November 16, 1998
- Date of Event
- October 19, 1998
- Report Date
- November 13, 1998
- Manufacturer
- CARL ZEISS, INC.
- Product Code
- EPT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ELECTRICAL FAILURE OF MICROSCOPE. SCOPE WAS NOT CHECKED PRIOR TO PROCEDURE. BIOMED CALLED TO FIND BLOWN FUSES CAUSED BY LOOSE CONNECTION IN LAMP HOUSING ASSEMBLY. REPLACED LAMP AND FUSE, RETESTED OK, UNIT RETURNED TO SVC. MFR NOTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZEISS | MICROSCOPE | EPT | CARL ZEISS, INC. | S22 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |