MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 8666

Device Problems Chemical Problem (2893); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by the manufacturing site.Device not returned to the manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of the washer - disinfectors: 8666.The initially received customer allegation was pointing to the door issues.While troubleshooting, the technician noticed also another issue related to enzyme wand.It was not dipped in the detergent, but floating freely in the bottle.And this situation could have resulted in detergent being not dispense properly.We were not informed about any adverse consequences related to this issue, however we decided to report this complaint in abundance of caution and based on the potential.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to find total of 4 reportable complaints for mixed detergents on 86-series devices, reported to company¿s complaint handling system within last 5 years.When the event occurred, the device likely did not meet its specification as due to the small amount of detergent pump during the cycle, the cleaning and disinfecting process could have been affected.There was however no actual technical malfunction found within the main device.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2000, type 8666 washer disinfector.During the investigation course, we were able to establish that the detergent wand was not dipped in the detergent, but floating freely in the bottle.This happened due as an effect of user changing the detergent container to a bigger one, which was not compatible with the old wand.The technician, who detected the issue was able to solve the problem by changing the want to the longer one.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.

• Brand Name: 86-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9725566
• MDR Text Key: 198538407
• Report Number: 9616031-2020-00007
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8666
• Device Catalogue Number: S-8666913-CTOM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1