FDA Adverse Event Malfunction Summary report: N

PORTABLE AC/DC SUCTION MACHINE

MDR report key: 20585214 · Received November 1, 2024

Report

Report Number
3003188183-2024-00001
Event Type
Malfunction
Date Received
November 1, 2024
Date of Event
September 25, 2024
Report Date
October 11, 2024
Manufacturer
VEGA TECHNOLOGIES INC.
Product Code
JCX
PMA / PMN Number
K102626
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

CAUSE ANALYSIS: A. ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER, THE PRODUCTION DATE IS OCTOBER 28, 2022. B. THE RETURNED PRODUCT WAS RECEIVED ON OCTOBER 30, 2024 (NO ACCESSORIES WERE RETURNED). C. THE APPEARANCE OF THE RETURNED PRODUCT WAS CONFIRMED, AND THE APPEARANCE OF THE RETURNED PRODUCT WAS GOOD. D. THE FUNCTION OF THE RETURNED PRODUCT WAS CONFIRMED, AND THE RETURNED PRODUCT WAS CONNECTED TO A 1000CC SUCTION CUP AND AN ADAPTER AS REQUIRED, AND THE PRODUCT SWITCH WAS TURNED ON. THE PRODUCT OPERATED NORMALLY, AND THE PRODUCT NEGATIVE PRESSURE AND MAXIMUM SUCTION FLOW WERE TESTED; THE MAXIMUM NEGATIVE PRESSURE, MINIMUM NEGATIVE PRESSURE AND MAXIMUM SUCTION FLOW OF THE PRODUCT WERE ALL WITHIN THE SPECIFICATION RANGE. E. DISASSEMBLE THE RETURNED PRODUCT, CHECK THE INTERNAL PIPE CONNECTION, TERMINAL CONNECTION AND WELDING SURFACE OF THE MACHINE, AND NO ABNORMALITY WAS FOUND VERIFICATION. A. CONNECT THE RETURNED PRODUCT TO A 1000CC SUCTION CUP AND AN ADAPTER, TURN ON THE RETURNED PRODUCT SWITCH, ADJUST THE NEGATIVE PRESSURE GAUGE TO THE MAXIMUM TO RUN THE MACHINE, AND RUN THE MACHINE CONTINUOUSLY FOR 24 HOURS WITHOUT ANY ABNORMALITY. VEGA WILL CONTINUE TO TEST. B. PLACE THE RETURNED PRODUCT ON THE VIBRATION TABLE, CONNECT THE 1000CC SUCTION CUP, CONNECT THE ADAPTER, TURN ON THE RETURNED PRODUCT SWITCH, ADJUST THE NEGATIVE PRESSURE GAUGE TO THE MAXIMUM, RUN THE MACHINE UNDER HORIZONTAL AND VERTICAL VIBRATION, CHECK WHETHER THE RETURNED PRODUCT WILL NOT WORK, AND NO ABNORMALITY WAS FOUND IN EACH MACHINE FOR 1H (SEE VIDEO 1 AND 2). C. WHEN THE LIQUID IN THE SIMULATED SUCTION CUP IS FULL TO THE MAXIMUM SCALE, IT IS NOT CLEANED IN TIME, RESULTING IN THE CLOSURE OF THE PROTECTIVE VALVE IN THE SUCTION COVER. D. WHEN THE WATER IN THE SUCTION CUP IS ADDED TO 1000ML, THE MOBILE BUOY FLOATS UP AND THE PROTECTIVE VALVE IN THE SUCTION COVER IS CLOSED (PIC.05 & PIC.06), TURN ON THE RETURNED PRODUCT SWITCH, AND THE RETURNED PRODUCT HAS NO SUCTION (THE PRODUCT CAN WORK NORMALLY). SUMMARY: THE RETURNED PRODUCT MACHINE HAS BEEN REPEATEDLY TESTED AND VERIFIED BY VEGA MANY TIMES AND IS A GOOD PRODUCT. THE VEGA MACHINE IS ALSO MATCHED WITH THE CUSTOMER'S SUCTION CUP ACCESSORIES. AFTER THE ABOVE VERIFICATION, THE REASONS FOR THE INTERMITTENT MALFUNCTION OF THE PRODUCT MAY BE. A. THE LIQUID IN THE SUCTION TANK IS FULL TO THE MAXIMUM SCALE BUT IS NOT CLEANED IN TIME, RESULTING IN NO SUCTION. AFTER CLEANING, THE PRODUCT RETURNS TO NORMAL. B. THE PROTECTIVE VALVE DEVICE IN THE SUCTION COVER IS ABNORMAL, RESULTING IN INTERMITTENT LACK OF AIR PRESSURE IN THE PRODUCT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1886269 PORTABLE AC/DC SUCTION MACHINE SUCTION MACHINE, PRODUCT CODE: LRQ JCX

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Hospitalization