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

Model Number 8668

Device Problem Device Handling Problem (3265)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of the investigation.Device not returned to manufacturer.

Event Description

On 1st october, 2021 getinge became aware of an event related to automatic loading system: ags (getinge automation system) used together with the washer disinfector, model name 8668 that took place on (b)(6) 2021.During the event the load cart was not automatically unloaded from the washer disinfector and the staff was unable to restart the system.As it was provided, the operator manually pulled the shuttle to the washer and pulled the load cart from the washer onto the asg system shuttle unloader.As an effect, the operator alleged to sustained a back injury.With the information received so far, we conclude that the injury did not require any medical intervention, however we decided to report the complaint based on the potential as we cannot exclude the possibility that if the situation was to reoccur, it would not contribute to the serious injury.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On october 1st, 2021 getinge became aware of an issue with the washer-disinfector with the model name 8668, with the catalog number s-86682003-ctom and the serial number (b)(6).The event took place on september 23rd, 2021.The unit was manufactured on may 6th, 2019 and installed on (b)(6) 2019.The washer-disinfector was used with getinge ags 2.0 with serial number (b)(6) as a system.The ags was manufactured on may 15th, 2019 and installed on (b)(6) 2019.The reported issue is related to operator injury while unloading load cart from the device.We were able to establish that this is one of a several reportable customer product complaint related to the injury while loading / unloading of the device involved on this type of devices reported within the last 5 years.The customer allegation was that the ags unit did not unload the load cart from the washer.The operator pushed the e-stop in order to stop the process.The staff also switched off the main power switch to reset the system, however it did not work as intended.The operator decided to unload the cart manually by pulling the shuttle to the washer and then pulling the load cart from the washer onto the ags shuttle unloader.The operator injured his back during this process.The getinge service technician visited the site and confirmed malfunction of the main power switch and lack of position magnet on load cart, which caused error of the ags.The main power switch was reconnected properly and missing position magnet was installed.The unit was restarted and returned to customer for service in fully operational state.The result of the investigation allows us to conclude that the most likely root cause of the issue is user error.The operator did not follow the user manual instruction, which describes correct unloading cart with use of the loading trolley, in case of system failure.Moreover, as no documentation regarding preventive maintenance activities could be provided, it can be assumed that the preventive maintenance routine was not followed, which would cover check of malfunctioning and missing parts.To prevent such situation in future customer was instructed that in all situations of ags failure, where the reset is not possible, the manual trolley should be used to remove the load cart from the washer safely.It was confirmed that when the event occurred, the device was directly involved and did not meet its specification as position magnet was missing and main switch was defective.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 of serious injury if the situation 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.

Event Description

Manufacturer`s reference number: (b)(4).

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer`s reference number: (b)(4).

• 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: 12591390
• MDR Text Key: 275217302
• Report Number: 9616031-2021-00031
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• 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,Followup,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male