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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES
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GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 8668T
Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.The device not returned to the manufacturer.
 
Event Description
On (b)(6) 2021 getinge received the information about the event which was related to 86-series washer disinfector with the model name 8668t.Due to the stop equipment missing, the instrument cart fell on the floor.There was no injury or damage reported, however we decided to report the issue based on a potential as instruments falling on the floor could bring a hazardous situation for the operator and lead to serious body injury if the situation was to reoccur.
 
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.The purpose of this submission is to provide a correction of #h4.Device manufacture date this is based on the result of an internal review noting the initial report was incorrectly submitted stating another manufacture date.#h4 previous device manufacture date#: 2021-10-14.Corrected device manufacture date#: 2021-10-12.
 
Event Description
Manufacturer's reference number: (b)(4).
 
Event Description
On 14th december, 2021 getinge received the information about the event which was related to 86-series washer disinfector with the model name 8668t.On (b)(6) 2021, it was confirmed that the device used with the washer disinfector was free standing unloading conveyor (fsuc) which is automatic unloading station.Due to the stop equipment missing, the instrument cart fell on the floor.There was no injury or damage reported, however we decided to report the issue based on a potential as instruments falling on the floor could bring a hazardous situation for the operator and lead to serious body injury if the situation was to reoccur.
 
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.The purpose of this submission is to provide an correction of #b5 describe event or problem due to new information provided: previous #b5 describe event or problem: on 14th december, 2021 getinge received the information about the event which was related to 86-series washer disinfector with the model name 8668t.Due to the stop equipment missing, the instrument cart fell on the floor.There was no injury or damage reported, however we decided to report the issue based on a potential as instruments falling on the floor could bring a hazardous situation for the operator and lead to serious body injury if the situation was to reoccur.Corrected #b5 describe event or problem: on 14th december, 2021 getinge received the information about the event which was related to 86-series washer disinfector with the model name 8668t.On (b)(6) 2022 it was confirmed that the device used with the washer disinfector was free standing unloading conveyor (fsuc) which is automatic unloading station.Due to the stop equipment missing, the instrument cart fell on the floor.There was no injury or damage reported, however we decided to report the issue based on a potential as instruments falling on the floor could bring a hazardous situation for the operator and lead to serious body injury if the situation was to reoccur.
 
Event Description
Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
On 14th december, 2021 getinge became aware of an issue related to free standing unloading conveyor (fsuc) used in the facility with one of the 86-series washer disinfectors.Customer reported switch got stuck, which resulted in cart falling off to the floor.The fsuc unloading device is not registered as a medical device, however upon the situation occurrence it was being used with washer disinfector 8668t as a system.Fully loaded cart falling off to the floor could bring a hazardous situation for the operator and lead to serious body injury if the situation was to reoccur, therefore we decided to report the complaint based on a potential.The device involved in the incident has been identified as a non-medical device ¿ free standing unloading conveyor (fsuc) with serial number: (b)(6) , manufactured in october 2021.In this particular case the device was used as a system with 86-series washer disinfector, 8668t model with following serial number: (b)(6) and udi (b)(4) , manufactured on 12th october 2021.As it was stated in the customer product complaint, the switch (part of the docking assembly) was found to be malfunctioning, so did not work as intended.The docking assembly includes a docking pin and docking sensor to control whether the trolley is correctly docked to the conveyer, as well as a stop pin which function is to stop the wash cart and prevent it from falling off the conveyor when the trolley is not docked in place.When the docking sensor was in the down position it was giving false signal that the trolley is docked properly when it was not.This led to the hazardous situation where the cart fall off from the unloader.During the investigation it was established that the unloader was installed at the facility in november 2021, so 2 months before the customer product complaint has been raised.Based on information gathered the docking micro switch needs to be adjusted during installation in line with the installation manual.The issue was consulted with the subject matter expert from the manufacturing site and as a result of the performed investigation, it was considered that the pin could have been not lubricated at the test run stage during installation, however this scenario seems unlikely since the system has been successfully running for 2 consecutive months without any issue.Therefore the most likely root cause was established as impossible to define.It was established that when the event occurred, the affected device did not meet its specification as a malfunction of the docking sensor occurred and led to the situation that the cart was nearly to fall and in this way the device contributed to reportable event.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.The problem has been resolved by lubrication of the docking switch on the conveyor.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
 
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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 Key13073545
MDR Text Key285259242
Report Number9616031-2021-00042
Device Sequence Number1
Product Code MEC
UDI-Device Identifier07340153710276
UDI-Public(01)07340153710276
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8668T
Device Catalogue NumberS-8668T1003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/12/2021
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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