MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number	88-5
Medical Device Problem Codes	Inadequate User Interface (2958); Device Handling Problem (3265)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue is being investigated by the manufacturing site.Device not returned to manufacturer.
Event or Problem Description
On 3rd march, 2020, getinge became aware about an event related to the automation loading system used with 88-5 washer disinfector.As it was stated, the operator wanted to fix the skewed objects placed on the rack moving along the working loader.The rack was close to the chamber, therefore the door of the washer opened and the users¿ arm was trapped between the door and the trolley.The operator sustained arm injury blue spot and slightly raised skin just above the elbow), however it was not classified as serious one.Nevertheless, we decided to report this complaint based on the potential for serious adverse outcome, if the situation was to reoccur.
Event or Problem Description
Manufacturer reference number (b)(4).
Additional Manufacturer Narrative
When reviewing reportable events for this type of issues we were able to establish, that the issue investigated herein is the fifth registered on the automatic loaders with the claim about the crush injury while operating the device.In all of those cases, the injury was classified as minor.The device involved in this event is the free standing loading conveyor used with the one of the washer disinfectors ¿ 88-5.The unit was manufactured on 17th october 2016.When the event occurred, the getinge device was directly involved.It likely did met its specification, as no technical malfunction was found on the device.Upon the event occurrence the device was not being used for patient treatment.The information collected to date and as a result of the performed investigation allowed us to establish that the operators¿ hand got stuck between the cart moving along the loader and the opened door.It happened due to the fact, that the operator tried to fix the object placed on the cart while the loader was working.In the user manual delivered with the automatic loaders it is stated, that the user is obligated to mark the units¿ working area with the yellow and black tape and the line should not be crossed why unit is in operation.If the user needs to touch the machine or fix something, first he should press the emergency stop button and then he can enter the working area.In summary, the most likely root cause of situation occurrence is related to activities performed by customer, which were not in line with steps given as part of the user manual.As the device had no mechanical malfunction and was returned to the usage, we currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however getinge will continue to monitor the customer experiences with the device for any future information.

• Brand Name: 88-SERIES
• Common Device Name: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9829114
• Report Number: 9616031-2020-00012
• Device Sequence Number: 2886561
• Product Code: MEC
• UDI-Device Identifier: 07340153700109
• UDI-Public: (01)07340153700109
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 88-5
• Device Catalogue Number: 88-303-CTOM
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1