FDA Adverse Event Malfunction Summary report: N

STEELCO

MDR report key: 21847536 · Received April 16, 2025

Report

Report Number
21847536
Event Type
Malfunction
Date Received
April 16, 2025
Date of Event
March 3, 2025
Report Date
April 14, 2025
Manufacturer
STEELCO S.P.A
Product Code
MEC
Product Problem
Yes
Report Source
User Facility report
Reporter Location
DC
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

OUTPATIENT SURGERY CENTER STAFF REPORTED A STRONG, UNIDENTIFIED SMELL IN BUILDING. INITIAL RESPONDERS ASSESSED THE SITUATION, CONDUCTING A VISUAL INSPECTION BUT DID NOT OBSERVE ANYTHING UNUSUAL. INQUIRED WITH THE NEARBY CONSTRUCTION TEAM ABOUT ANY ONGOING ACTIVITIES SUCH AS WELDING, HEAVY GLUE USAGE, OR SIMILAR WORK THAT COULD PRODUCE THE SMELL¿NONE WERE REPORTED. INITIAL RESPONDER CONTACTED THE BUILDING MANAGER TO ASSIST WITH THE ASSESSMENT. UPON CHECKING THE SECOND FLOOR, SPD TECHNICIAN REPORTED SEEING A SMALL AMOUNT OF SMOKE COMING FROM THE WASHER. TURNED OFF THE WASHER AND ITS CIRCUIT BREAKER AND CEASED ALL USE OF THE MACHINE TO PREVENT FURTHER RISK. USERS THEN CONTACTED THE BIOMEDICAL ENGINEERING TEAM FOR FURTHER ASSESSMENT. BIOMEDICAL STAFF ARRIVED AND INSPECTED THE WASHER; IDENTIFIED INTERNAL MELTED CABLES AS THE CAUSE OF THE SMOKE AND ODOR. NO FLAMES OR ACTIVE FIRE WERE OBSERVED, ONLY A SMALL AMOUNT OF SMOKE WAS PRESENT. NO STAFF MEMBERS WERE HARMED; NO PATIENTS WERE AFFECTED. NO SURGICAL CASES WERE CANCELED. THE WASHER WAS ASSESSED BY VENDOR STEELCO, REPAIRED, AND RETURNED TO SERVICE. THE ROUTINE PREVENTATIVE MAINTENANCE (PM) WAS COMPLETED BY VENDOR ON [DATE REDACTED], JUST A FEW DAYS PRIOR TO INCIDENT. NO ISSUES WERE NOTED DURING PM. MANUFACTURER RESPONSE FOR STEELCO WASHER, (BRAND NOT PROVIDED) (PER SITE REPORTER). MANUFACTURER CAME ONSITE FOR ASSESSMENT AND REPAIRS. MULTIPLE SITE VISITS REQUIRED TO COMPLETE REPAIR; DEVICE RETURNED TO SERVICE 3/17/25.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
113603 STEELCO DISINFECTOR, MEDICAL DEVICES MEC STEELCO S.P.A DS 500 CDL

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown