MAUDE Adverse Event Report: GETINGE GROUP WASHER/DISINFECTOR; DISINFECTOR, MEDICAL DEVICES

Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911); Misassembly by Users (3133)

Patient Problem No Information (3190)

Event Date 03/22/2018

Event Type  malfunction  

Event Description

Sterile processing noticed that a washer was leaking and removed it from service.The vendor came in to evaluate on (b)(6) and identified that the lubricant and detergent bottles were hooked up to the wrong fill lines.This caused the washer cycle to occur in the wrong order.The load had to be re-run.This is a newer washer and it appears that the line were not marked when the unit was installed as to what bottle went where.It is also an identified problem that both the lubricant and detergent can be hooked to the same line - this is definitely a design flaw and should be connected.

• Brand Name: WASHER/DISINFECTOR
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE GROUP
• MDR Report Key: 7560578
• MDR Text Key: 109904777
• Report Number: MW5077583
• Device Sequence Number: 1
• Product Code: MEC
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other