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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 8668
Device Problems Mechanical Jam (2983); Device Handling Problem (3265)
Patient Problem Muscle/Tendon Damage (4532)
Event Date 03/21/2022
Event Type  Injury  
Event Description
On (b)(6) 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8668.During the getinge technician visit on customer site he was informed about an incident on the machine, which took place on (b)(6) 2022.As it was stated, a staff member tried to manually remove a trolley from the washer.She was injured on the wrist.In more details, at the end of the cycle, the trolley remained stuck in the machine and the staff member began to extract the trolley by hand, positioning herself on the side of the unloading surface.The injury involves a lesion at the level of a tendon on the outer surface of the right wrist.The person has been immobilized for the moment, and must undergo examinations, which will decide on the need to operate or not.The injury has been classified as serious as medical intervention was needed to preclude long term consequences.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.
 
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
On (b)(6) 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8668.During the getinge technician visit on customer site he was informed about an incident on the machine, which took place on (b)(6) 2022.As it was stated, a staff member tried to manually remove a trolley from the washer.She was injured on the wrist.In more details, at the end of the cycle, the trolley remained stuck in the machine and the staff member began to extract the trolley by hand, positioning herself on the side of the unloading surface.The injury involves a lesion at the level of a tendon on the outer surface of the right wrist.The person has been immobilized for the moment, and must undergo examinations, which will decide on the need to operate or not.The injury has been classified as serious as medical intervention was needed to preclude long term consequences.On (b)(6) 2022 we received information that the injured operator has been immobilized with a plaster cast above her elbow.So far, no other intervention has been undertaken.
 
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's reference number: (b)(4).
 
Manufacturer Narrative
On april 29th, 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8668, and the serial number (b)(6).The unit was manufactured on september 25th, 2015.The reported incident took place on march 21st, 2022.The customer allegation was that; the operator injured her wrist during removing the trolley manually from the washer.The device was used with an automatic unloader.The cart did not come out from the washer-disinfector and stuck in the machine at the end of the cycle.The operator tried to remove the trolley by hand, which caused her injury involving a lesion at the level of the tendon on the outer surface of the right wrist.The operator was temporarily immobilized.On july 19th, 2022 we were informed that the injured operator needed longer immobilization with a plaster cast above her elbow.So far, no other information about operator¿s condition has been provided.The getinge service technician visited the site and no device malfunction has been identified.Moreover, the device logs were analyzed and no errors or alarms were found.The analysis also showed that the emergency stop was not pushed.The washer-disinfector was inspected and maintained after the incident and returned to use in a fully operational state.Based on the collected information, the exact root cause of the device stuck could not be confirmed.Nevertheless, the result of the investigation allows us to conclude that the operator did not follow safety instructions from the user manual, which directly led to the injury.The risk zone of the device should not have been entered without pressing the emergency stop first.In case of the malfunction, unit should be reset and further service technician should be contacted if this would not work.It has been also determined that the machine working area was not marked out on the floor as it is described in the user manual.Taking the above into account the root cause is defined as a user error.To prevent such situation the customer will be reminded about the content of the user manual.We were able to establish that this is one of a several reportable customer product complaints related to the issue involved on this type of devices reported within the last 5 years.It was confirmed that when the event occurred, the device was directly involved, however we could not confirmed that it did not meet its specification.The device was not being used for treatment or diagnosis of the patient.The injury has been classified as serious as medical intervention was needed to preclude long term consequences.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.
 
Event Description
Manufacturer's reference number: (b)(4).
 
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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 Key14344599
MDR Text Key294680045
Report Number9616031-2022-00008
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeBE
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 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number8668
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/17/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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