MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES WASHER DISINFECTOR; MEC

Model Number	88-5
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed under exemption e2017050 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge group logistic america, llc, (registration no.3012092534).When reviewing reportable events for the same issue we have been able to establish that the issue is considered to be a single, isolated event.The product involved in the incident is a 88-series washer disinfectors with serial number: (b)(4), manufactured on 16th of september 2014.Dhr of the device was reviewed and it did not provide any relevant information.There was no anomalies detected during the manufacturing process.Upon the issue occurrence, the washer disinfector has been used together with a free standing loading conveyor ( fslc).With the complaint at hand we have received an information that arm of the operator was caught between washer disinfector and the cart, while the load has been already transferred into the washer chamber by the free standing loader.After the incident occurrence, the person went to the emergency department where, after the assessment, it has been confirmed that the arm was not broken and the person was sent back home.The serious injury has been excluded and, to date, we have received no information about any injury sustained as an effect of this situation.Nevertheless, since an adverse event occurred we decided to report this complaint to competent authorities based on the potential and in abundance of caution.User manual for getinge 88-series washer disinfector (6001234702, rev.H) clearly states that operators and maintenance personnel must have completed training through the marketing organization of getinge.Additionally, it includes all necessary information regarding device safety usage and how to properly load and unload the cart.Based on the collected information we have confirmed that upon the incident occurrence, the operator involved was not trained as required.The incident took place when he operator attempted to adjust the load on the cart while it was entering the washer disinfector's chamber.As per the user manual for the free standing conveyor (504271000 rev.A) the movement of the cart should be stopped before any adjustment is made, by pressing the stop button.The movement of the cart can be activated again by releasing the button.Based on the performed investigation we have concluded the root cause of the incident is to user error.If the customer would followed the recommendation included in the user manual the event could have been avoided.
Event or Problem Description
On 2nd of august 2018 getinge became aware of an situation where an arm of operator was caught between washer disinfector and the cart transferred into the washer by the free standing loader.After the incident occurrence, the person went to the emergency department where, after the assessment, it has been confirmed that the arm was not broken.

• Brand Name: 88-SERIES WASHER DISINFECTOR
• Common Device Name: MEC
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• MDR Report Key: 7817431
• Report Number: 9616031-2018-00009
• Device Sequence Number: 1011975
• Product Code: MEC
• UDI-Device Identifier: 07340153700109
• UDI-Public: 07340153700109
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

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: Health Professional
• Device Model Number: 88-5
• Device Catalogue Number: 88-303
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other