FDA Adverse Event Malfunction Summary report: N

STREAMWAY

MDR report key: 21772860 · Received April 4, 2025

Report

Report Number
21772860
Event Type
Malfunction
Date Received
April 4, 2025
Date of Event
January 23, 2025
Report Date
March 20, 2025
Manufacturer
SKYLINE MEDICAL INC.
Product Code
GCX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WI
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

WE KEEP HAVING REPEATED ISSUES ON TWO OF OUR BRAND-NEW UNITS (SERIAL# [REDACTED] AND SERIAL # [REDACTED]). SINCE [REDACTED], THEY EACH HAVE HAD 7 SERVICE REQUESTS SUBMITTED - ABOUT ONE A WEEK ON BRAND NEW UNITS WHERE I¿D EXPECT FEW CALLS ON. COMMON THEMES: BLUE FLUID IN BACK RESERVOIR CHAMBER, BLUE FLUID IN VACUUM TANK TRAP, RED FLOAT ALARM (FLUID IN VACUUM TANK?). WE DON¿T HAVE SEEM TO BE HAVING ISSUES ON THE OTHER 8 NEW UNITS. WITH OUR PROBLEMS LIMITED TO TWO SERIAL NUMBERS, WE REQUESTED THEY BE SWAPPED OUT/EXCHANGED AS LEMONS UNDER WARRANTY, BUT THE VENDOR HAS NOT COMPLIED. MANUFACTURER RESPONSE FOR WASTE FLUID MANAGEMENT SYSTEM, STREAMWAY (PER SITE REPORTER). REPLACEMENT SYSTEMS UNDER WARRANTY: WE ARE CONFIDENT THAT EACH STREAMWAY® SYSTEM (SERIAL NO. [REDACTED] & SERIAL NO. [REDACTED]) IS PERFORMING AS DESIGNED, AND WE WOULD WITHOUT QUESTION REPLACE THE SYSTEMS; HOWEVER, WE ARE MOST CERTAIN THIS WILL NOT CHANGE THE CURRENT STATE OF CLEANING SOLUTION FLUID ACCUMULATING THE BACKFLOW RESERVOIR TANK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1263646 STREAMWAY APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX SKYLINE MEDICAL INC. 4501.3000

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown