FDA Adverse Event Malfunction Summary report: N

MEDICAL PURPOSE COMPUTER; ESOPHAGEAL MANOMETER

MDR report key: 1822175 · Received August 5, 2010

Report

Report Number
1822175
Event Type
Malfunction
Date Received
August 5, 2010
Date of Event
July 16, 2010
Report Date
August 5, 2010
Manufacturer
SIERRA SCIENTIFIC INSTRUMENTS LLC
Product Code
FFX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

A PT WAS SCHEDULED FOR AN ESOPHAGEAL MANOMETRY WHICH WAS PERFORMED ON A SEIRRA SCIENTIFIC HIGH RESOULTION MANOMETRY COMPUTER A HIGH RESOULTION MANOMETRY CATHETER WAS PLACED INTRANASALLY IN THE PT AND PROTOCOL FOR THE TEST WAS PERFORMED. DUE TO A HIGH VOLUME OF PT FLOW IN THE AREA, THE COMPUTER WAS LEFT RECORDING AFTER THE TEST WAS COMPLETED. NORMALLY ONCE THE PT IS EXTUBATED, A FILE WOULD BE SAVED WITH PT'S NAME AT ONCE. WHEN THE TRACING WAS SAVED APPROXIMATELY ONE HOUR LATER, ALL THAT WAS FOUND UNDER THE PT'S NAME WAS A BLANK TRACING. WHEN THE COMPANY WAS CONTACTED AND THE INCIDENT WAS EXPLAINED, A DUPLICATED TEST SAMPLE WAS RUN AND THEY DISCOVERED A "GLITCH" IN THE SOFTWARE. WHEREBY, THE SOFTWARE ONLY SAVES THE LAST SIXTY MINUTES OF A TRACING, ANYTHING BEFORE THAT IS DEFAULTED TO AN OVERWRITE. IN SHORT, THE ACTUAL TRACING WAS NEVER SAVED ONLY THE BLANK RECORDING. WE ARE AWAITING A RESPONSE FROM THE MFR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDICAL PURPOSE COMPUTER; ESOPHAGEAL MANOMETER SYSTEM, ELECTRICAL, GASTROINTESTINAL, MOTILITY FFX SIERRA SCIENTIFIC INSTRUMENTS LLC OPTIPLEX760 ---

Patients

Seq Age Sex Outcome Treatment
1 79 YR