MalfunctionFFX

SANDHILL SCIENTIFIC

Received Apr 6, 2020 · Event occurred Feb 11, 2020

Report 9928136 · MDR key 9928136

Device

Generic name

System, Gastrointestinal Motility (electrical)

Manufacturer

Diversatek Healthcare, Inc.

Model number

DPQTQG2

Product problems

Failure to Calibrate

Patient

Not reported

No Patient Involvement
No Patient Involvement

Narrative

Description of Event or Problem

SANDHILL MANOMETRY EQUIPMENT UNABLE TO CALIBRATE CATHETER PRIOR TO PROCEDURE. CLINICAL ENGINEERING TECH IN UNIT AND TROUBLE SHOOTING. SANDHILL REPRESENTATIVE CALLED AND UNABLE TO ASSIST WITH REPAIR. SANDHILL TECHNICAL SUPPORT CALLED AND HAD TO LEAVE MESSAGE BECAUSE CALL CENTER IS IN (B)(6). PATIENT WAS UNFORTUNATELY ALREADY PRESENT AT FACILITY, SO I SPOKE WITH HIM AND EXPLAINED SITUATION. HE AND WIFE WERE VERY UNDERSTANDING. WAITING TO HEAR FROM SANDHILL AND CLINICAL ENGINEERING FOR NEXT STEP IN TROUBLE SHOOTING.