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

Model Number 8666

Device Problem Unintended System Motion (1430)

Patient Problem Laceration(s) (1946)

Event Date 11/27/2021

Event Type  Injury  

Event Description

On 18th january, 2022 getinge became aware of an event related to automatic loading system: ags used together with the washer from the 86-series.The event occurred on (b)(6) 2021 and it was directly reported by the facility to the fda and registered under report number (b)(4).As it was stated the racks jammed and the unit alarmed.The operator stated the unit was hooked to the washer disinfector rack and the person attempted to evaluate the cause.At this point, the operator`s right hand was caught and right finger was cut.The injury was classified as serious as three stitches were needed.Reference- (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On 18th january, 2022 getinge became aware of an event related to 86-series washer disinfector.During investigation course we were able to establish that the washer disinfector was used with the automation loading system ¿ free standing conveyor (fsc).The fsc has the serial number (b)(6) and was manufactured on 29th august, 2013.The unit is under getinge preventive maintenance agreement and services performed on august, november, 2021 and february, 2022 showed no malfunctions.The reported issue is related to a finger cut requiring stitches sustained while operating the fsc.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.The review also shows that there are previous registered customer product complaints that resulted in serious injuries while operating the automation loading system.During the investigation we were able to establish that after the wash cart was jammed and the alarm was raised, the operator tried to resolve the issue.During the troubleshooting the operator`s hand was caught by the part that is designed to unload the wash carts from the washer disinfector and the finger was cut.The injury required stitches and was classified as serious.Taking into the consideration all information available it was determined by the subject matted expert from the manufacturing site that the most likely root cause of the event was related to a user error.The user manual describes that the emergency stop should be pressed at first when the operational malfunction occurs.Nevertheless, in this specific event, the operator most probably entered the machine's working area, not following the requirements from the user manual and not activating the emergency stop as first.It directly resulted in serious injury.At the time of the event occurrence the unit was directly involved.The cart was jammed during automatic process, therefore it is concluded the device was not up the manufacturer specification at the time of the event.However, we could not contact the customer, therefore the reason of jammed cart have not been determined.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.

• 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: 13342706
• MDR Text Key: 289079654
• Report Number: 3012092534-2022-00001
• 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
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8666
• Device Catalogue Number: S-8666913-CTOM
• 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: 06/01/2022
• Distributor Facility Aware Date: 05/04/2022
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Date Manufacturer Received: 05/04/2022
• 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