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

Model Number 8666

Device Problems Failure to Pump (1502); Pumping Problem (3016)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 28th february, 2019 getinge became aware of an issue with one of the washer-disinfectors, 8668.The first customer allegation was that the detergent is not dosing.The technician arrived on site and found the detergent pump not operational.We were not able to confirm who and when noticed the problem and if any loads were processed without the proper detergent dosage.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.

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to find total of 5 reportable complaints for detergent dosing malfunction on 86-series devices, reported to company¿s complaint handling system within last 5 years.When the event occurred, the device did not meet its specification.Upon the event occurrence the device was not being used for patient treatment.The complaint was decided to be reported to authority in abundance of caution.The device affected is a 2002, type 8666 washer disinfector.During the investigation course, we were able to establish that the detergent pump on the machine was non-operative and the detergent hoses were squeezed.The detergent was most likely not pumped during the washing cycle and therefore the cleaning and disinfecting process could have been affected.This happened as a result of the normal wear of those parts related to prolonged usage of the unit.The technician, who detected the issue was able to solve the problem by changing the affected parts for the new ones.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.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 86-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9888297
• MDR Text Key: 200053234
• Report Number: 9616031-2020-00016
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

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: Health Professional
• Device Model Number: 8666
• Device Catalogue Number: S-8666913-CTOM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1