MalfunctionHGX

UNIMOM OPERA

Received Jul 22, 2025 · Event occurred Jul 10, 2025

Report MW5173054 · MDR key 22568533

Device

Generic name

Pump, Breast, Powered

Manufacturer

Unimom Co

Model number

OPERA

Product problems

Decrease in Suction
Suction Failure
Decrease in Suction
Suction Failure

Patient

30 YR · Female

Breast Feeding Problem
Breast Feeding Problem

Narrative

Description of Event or Problem

BREAST PUMP LOST SUCTION AFTER 8 MONTHS OF USE AND MAKES A CLUNKING NOISE WHEN USED. THE RIGHT SIDE OF THE PUMP HAS LESS SUCTION THAN THE LEFT SIDE. NOT FIXED BY SWAPPING PUMP TUBING OR FLANGE SETUP. CONTACTED THE MANUFACTURER ABOUT THE ISSUE AND WAS SENT A NEW LOANER PUMP. RIGHT OUT OF THE BOX THE NEW LOANER PUMP HAD NO SUCTION ON THE RIGHT SIDE AT ALL. LEFT SIDE WORKED OK. SWITCHED TUBING AND FLANGE SETUPS AND THE SET THAT DIDN'T WORK WHEN CONNECTED TO THE RIGHT-SIDE WORKS WHEN CONNECTED TO THE LEFT, SO THE ISSUE IS THE PUMP. LOSING BREAST MILK SUPPLY BECAUSE OF THIS ISSUE. HAVE VIDEOS OF THE PUMPS AVAILABLE IF NEEDED. PATIENT: 4829. DEVICE:1146; 4039. REFERENCE REPORT: MW5173053.