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

Model Number 8668

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge received an information about the event which was related to the washer disinfector with the model name 8668 used with the getinge air glide system (ags).The ags is fully automatic and highly flexible loading and transport system for the washer disinfectors.As it was stated, the stop feature did not work, and in consequence the rack fell to the floor.There was no injury or damage reported so far, however we decided to report the issue based on a potential as rack falling to the floor could bring a hazardous situation for the operator and lead to serious injury if the situation was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.

Event Description

Manufacturer reference number: ot (b)(4).

Manufacturer Narrative

On (b)(6), 2022, getinge became aware of an issue with the getinge ags 2.0 (air glide system) used with the 86-series washer-disinfectors.The ags 2.0 serial number is (b)(6).The unit was manufactured on (b)(6), 2015.The ags 2.0 is an automatic and flexible loading and transport system for the washer-disinfectors.The reported issue is related to the rack falling to the floor from the ags 2.0 conveyor.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that would warrant further scrutiny.The customer allegation was that the stop pin did not work and the rack fell to the ground in a result.The stop pin is a part of the ags 2.0, which is pressed when the loading / unloading trolley is connected to the device.It prevents the racks to fall off when the trolley is not connected.The getinge service technician visited the site and confirmed malfunction of the stop pin, which has not been giving its full and continuous range of motion.The result of the investigation allows us to conclude that problem is a consequence of the stop pin being stuck in pushed position.It is related to the stop pin assembly issue.The whole docking assembly (which includes the stop pin) was replaced and the device was handed over for the customer use.It was confirmed that when the event occurred, the device was directly involved and did not meet its specification, as the stop pin did not work and consequently the rack fell to the floor.The situation can lead to the body injury.The device was not being used for treatment or diagnosis of the patient.We are not aware if the described issue caused or contributed to the serious injury or worse, however we report the event based on the potential for serious injury if the issue was to reoccur.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
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 14590075
• MDR Text Key: 301031066
• Report Number: 9616031-2022-00011
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1