FDA Adverse Event
Malfunction
Summary report: N
FUSE SYSTEMS
MDR report key: 6047876
·
Received October 21, 2016
Report
- Report Number
- 3007591333-2016-00052
- Event Type
- Malfunction
- Date Received
- October 21, 2016
- Date of Event
- September 21, 2016
- Report Date
- October 11, 2016
- Manufacturer
- ENDOCHOICE, INC.
- Product Code
- FDF
- PMA / PMN Number
- K141598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS DETERMINED THAT THE ISOLATION TRANSFORMER MALFUNCTIONED AND A REPLACEMENT ISOLATION TRANSFORMER WAS SENT TO THE SITE RESOLVING THE ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MONITOR SHUT DOWN DURING A PROCEDURE DUE TO THE ISOLATION TRANSFORMER POWERING DOWN. THE DEVICES WERE THEN PLUGGED DIRECTLY INTO A WALL OUTLET AFTER WHICH THE MONITOR CAME BACK ON. THERE AS NO PATIENT INJURY OR OTHER ADVERSE HEALTH CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 699410 | FUSE SYSTEMS | COLONOSCOPE AND ACCESSORIES | FDF | ENDOCHOICE, INC. | ISOLATION TRANSFORMER 1000 VA - 8 OUTLET COMPACT (100-120VAC) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |