FDA Adverse Event
Malfunction
Summary report: N
HIGH RESOLUTION ESOPHAGEAL MANOMETRY-PC
MDR report key: 1813599
·
Received July 28, 2010
Report
- Report Number
- 1813599
- Event Type
- Malfunction
- Date Received
- July 28, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 23, 2010
- Manufacturer
- SIERRA SCIENTIFIC INSTRUMENTS, INC.
- Product Code
- FFX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE PT COMPLETED A HIGH RESOLUTION ESOPHAGEAL MANOMETRY-PC ON LAST MONTH. THE STUDY WENT WELL WITHOUT COMPLICATIONS. HOWEVER, AFTER THE PT WAS EXTUBATED, THE STUDY WAS ATTEMPTED TO BE SAVED TO THE HARD DRIVE, YET A SOFTWARE MALFUNCTION DELETED THE STUDY. THE PT WAS RE-SCHEDULED AND THE STUDY WAS COMPLETED THE NEXT DAY WITHOUT COMPLICATIONS. THE SOFTWARE COMPANY, SIERRA SCIENTIFIC,WAS CONTACTED AND INFORMED OF A MISSING STUDY ALONG WITH THE HOSPITAL'S BIO MED REPRESENTATIVE FOR THE MEDICAL PROCEDURE UNIT (MPU). TECH SUPPORT WAS UNABLE TO LOCATE THE STUDY ON THE HARD DRIVE. THE EXPLANATION FROM SIERRA SCIENTIFIC'S TECH SUPPORT WAS UNDETERMINED. THE POSSIBLE CAUSE OF THE MALFUNCTION WAS DUE TO AN ERROR IN SOFTWARE'S SMART MOUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIGH RESOLUTION ESOPHAGEAL MANOMETRY-PC | SYSTEM, GASTROINTESTINAL, MOTILITY, HIGH RESOLUTION ESOPHAGE | FFX | SIERRA SCIENTIFIC INSTRUMENTS, INC. | OPTIPLEX760 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |