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

Model Number 8666

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 getinge became aware of an issue with one of washer disinfectors (b)(4).As it was stated by the customer, the trolleys used together with the washer disinfector were falling off of the transfer trolleys on the floor.There was no injury reported however we decided to report the issue based on the potential as any trolleys falling off might cause an injury.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by the manufacturing site, however it was confirmed that the trolleys which played role in the issue at hand were manual transfer trolleys for the model 8666 washer disinfectors.

Manufacturer Narrative

The issue in being investigated by a manufacturer site.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue in being investigated by a manufacturer site.

Manufacturer Narrative

Issue is being investigated by the manufacturer.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Information was received indicating the allegation of the rack falling of a manual trolley ¿ a washer disinfector accessory.When reviewing reportable events for this type of issues we found a low baseline of event occurrence.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 device affected is a manual loading trolley, accessory dedicated to be used with the 8666 washer disinfector.During the investigation course, the getinge technician inspected accessory of this kind available at the customer site and found 6 units with missing end stop pins- a part that exists to avoid a cart movement when placed on the trolley.The service technician ordered the missing parts and installed them on the trolleys, therefore the problem was solved at the affected facility.The complaint was investigated by the subject matter expert (sme) from the manufacturing site who confirmed that the ring, which is to fasten and hold the pin in place can become bent and lose their functionality during the usage of the cart.As a result, the ring eventually breaks and consequently the pin falls off the trolleys causing the cart docking mechanism failing their function.

• Brand Name: 86-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9086963
• MDR Text Key: 195578501
• Report Number: 9616031-2019-00028
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8666
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1