MAUDE Adverse Event Report: BELIMED AG MEDICAL EQUIPMENT WASHER; DISINFECTOR, MEDICAL DEVICES

Model Number WD290

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2022

Event Type  malfunction  

Event Description

Belimed service technician arrived to fix washer leak.Following "repair" during validation testing, the washer began malfunctioning and is unable to run any cleaning cycles.Fda safety report id# (b)(4).

• Brand Name: MEDICAL EQUIPMENT WASHER
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): BELIMED AG
• MDR Report Key: 13424553
• MDR Text Key: 285004678
• Report Number: MW5107122
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WD290
• Device Catalogue Number: WD290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1