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

Model Number 8668

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Skin Tears (2516)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an event related to automatic loading system: ags associated with the washer from the 86-series with the model name 8668.The customer informed that one of the staff member put a hand on the unloading arm of the ags that is intended to pull the basket out of the washer disinfector.When the ags began to work, the unloading arm move forward and caught the staff member`s finger.The customer contact provides that the staff member's finger had to have stitches.The injury was classified as serious as the medical intervention was needed.(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 reference number: (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On 15th december, 2021, getinge became aware of an issue with automation system (ags) used together with 8668 washer disinfector.The ags has the serial number (b)(6) and it was manufactured on 29th august, 2013.The installation date of the device in the facility is (b)(6), 2014.The unit is under getinge preventive maintenance.The reported issue is related to a finger injury requiring stitches sustained while operating the ags.The review of reportable events registered in the company¿s complaint handling system within last 5 years was performed.It revealed that the complaint is one of several reported cases with the allegation about injury occurrence while operating the automation loading system and this complaint is the (b)(4) complaint in which the serious injury occurred.During the investigation we were able to establish that the event occurred while the hand was put on the unloading arm of the ags.The arm is designed to pull the basket out of the washer disinfector.When the ags began to work, the unloading arm moved forward and caught the staff member`s finger.The injury required stitches.During the preventive maintenance done on 23rd february, 2022 the unit was evaluated and no malfunction was found.Taking into the consideration all information available it was determined by the subject matter expert from the manufacturing site that the most likely root cause of the event was related with an user error.The user manual describes that the machine should be stop when the machine working area is entered.The operator shall pay attention and be careful with the machine¿s moving parts.The working area is also describes as a risk zone and it is marked out by the customer using the yellow/black markings as additional warnings for operators.The unit is also marked with warning symbols to indicate risk zone.Nevertheless, in this specific event, the operator most probably entered the machine's working area, mentioned warnings were not followed and it directly resulted in serious injury.At the time of the event occurrence the unit was directly involved.However, we have no evidence that would allow as to confirm that the unit failed to meet its specifications as no technical deficiency was found on the device.In addition, none of the provided information indicates that upon the event occurrence the device was being used for patient treatment.We believe that devices in the market are performing correctly overall.Given the circumstances, we shall continue to monitor for any further events of this nature.The purpose of this submission is also to provide a correction of #b1 type of report.This is based on the result of an internal review noting the initial report was incorrectly submitted stating another type of report.#b1 previous type of report#: adverse event & product problem corrected type of report#: adverse event.

• 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: 13060314
• MDR Text Key: 282618408
• Report Number: 3012092534-2021-00004
• 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: Distributor
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2022
• Distributor Facility Aware Date: 05/13/2022
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2022
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male