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

Model Number 8668

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Crushing Injury (1797)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge received information about the event that took place on (b)(6) 2021.As it was stated the operator`s hand was pinched between the loader/unloader moving arm of the 86 ¿ series washer disinfector and a wash cart.During the event, the operator activated the emergency stop button in the loader/unloader but it did not release the moving arm.Another operator moved the arm in the loader/unloader, which allowed the injured operator to pull out his/her pinched hand.The person who has pinched hand is away and will return to work on (b)(6) 2022.Based on the available information we cannot classify the health impact.However; we decided to report the issue in abundance of caution and based on the potential as we cannot confirm that similar events could not contributed to the serious injury if reocur.

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 3rd may, 2022 getinge received information about the event that took place on 10th november, 2021.As it was stated the operator`s hand was pinched between the loader/unloader moving arm of the 86 ¿ series washer disinfector and a wash cart.During the event, the operator activated the emergency stop button in the loader/unloader but it did not release the moving arm.Another operator moved the arm in the loader/unloader, which allowed the injured operator to pull out his pinched hand.Additional information, received on may 13th, 2022, allowed us to establish that the injury resulted in bruising and a sore arm for some time.No sick leave was prescribed.With the information received so far, we conclude that the injury did not require any medical intervention, however we decided to report the issue in abundance of caution and based on the potential for serious injury if the situation was to reoccur.

Manufacturer Narrative

Previous additional manufacturer narrative: on 3rd may, 2022 getinge became aware of an issue with free standing loading conveyor (fslc) which took place on 10th november, 2021.The serial number of the unit is (b)(6).The fslc is an automatic system for loading wash carts for getinge 86/88/cm320-series washer-disinfectors.The fslc is a non-medical device that was used with the washer disinfector with the model name 8668 and the serial number (b)(6) when the event occurred.The washer disinfector was manufactured on 4th april, 2016 and installed in facility on 19th april, 2016.Upon issue occurrence, the device was not under getinge preventive maintenance agreement.It was alleged that the device operator`s hand became stuck between the wash cart and the free standing loading conveyor (fslc).The help of a second operator was indicated to have been necessary to pull out his hand.Related information received by getinge on 13th may, 2022 indicates that there was an injury which was described as bruising and a sore arm for some time and sick leave.There was no confirmed information if any medical intervention was required.The hospital service manager suspected that an ice pack was needed after the event, however the information could not be confirmed.Based on the information obtained, it appears there were no serious consequences.We were able to establish that this is one of several reportable customer product complaint related to an allegation of injury or harm while handling the automatic system used with washer disinfectors reported, within the last 5 years.The review did not provide any signals that would warrant further analysis.Taking into the consideration all information available it was determined by the subject matter expert from the manufacturing site that the most likely root cause of the event was related with a user error.The user manual describes that the machine should be stopped when the machine working area is entered.The operator is to pay attention and be careful with the machine¿s moving parts.The working area is also described as a risk zone and it is marked out to the user by the yellow/black markings as additional warnings for operators.The unit is also marked with warning symbols to indicate risk zone.Nevertheless, in this specific event, the operator entered the machine's working area, most probably not following mentioned warnings and it directly resulted in the reported situation.At the time of the event occurrence the unit was directly involved.However, we have no evidence that would allow to confirm that the unit failed to meet its specifications as the device was working as intended and no technical deficiency was reported.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.Corrected additional manufacturer narrative: on 3rd may, 2022 getinge became aware of an issue with free standing loading conveyor (fslc) which took place on 10th november, 2021.The serial number of the unit is (b)(6).The fslc is an automatic system for loading wash carts for getinge 86/88/cm320-series washer-disinfectors.The fslc is a non-medical device that was used with the washer disinfector with the model name 8668 and the serial number (b)(6) when the event occurred.The washer disinfector was manufactured on 4th april, 2016 and installed in facility on 19th april, 2016.Upon issue occurrence, the device was not under getinge preventive maintenance agreement.It was alleged that the device operator`s hand became stuck between the wash cart and the free standing loading conveyor (fslc).The help of a second operator was indicated to have been necessary to pull out his hand.Related information received by getinge on 13th may, 2022 indicates that there was an injury which was described as bruising and a sore arm for some time and no sick leave.There was no confirmed information if any medical intervention was required.The hospital service manager suspected that an ice pack was needed after the event, however the information could not be confirmed.Based on the information obtained, it appears there were no serious consequences.We were able to establish that this is one of several reportable customer product complaint related to an allegation of injury or harm while handling the automatic system used with washer disinfectors reported, within the last 5 years.The review did not provide any signals that would warrant further analysis.Taking into the consideration all information available it was determined by the subject matter expert from the manufacturing site that the most likely root cause of the event was related with a user error.The user manual describes that the machine should be stopped when the machine working area is entered.The operator is to pay attention and be careful with the machine¿s moving parts.The working area is also described as a risk zone and it is marked out to the user by the yellow/black markings as additional warnings for operators.The unit is also marked with warning symbols to indicate risk zone.Nevertheless, in this specific event, the operator entered the machine's working area, most probably not following mentioned warnings and it directly resulted in the reported situation.At the time of the event occurrence the unit was directly involved.However, we have no evidence that would allow to confirm that the unit failed to meet its specifications as the device was working as intended and no technical deficiency was reported.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.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On 3rd may, 2022 getinge became aware of an issue with free standing loading conveyor (fslc) which took place on 10th november, 2021.The serial number of the unit is (b)(6).The fslc is an automatic system for loading wash carts for getinge 86/88/cm320-series washer-disinfectors.The fslc is a non-medical device that was used with the washer disinfector with the model name 8668 and the serial number (b)(6) when the event occurred.The washer disinfector was manufactured on 4th april, 2016 and installed in facility on 19th april, 2016.Upon issue occurrence, the device was not under getinge preventive maintenance agreement.It was alleged that the device operator`s hand became stuck between the wash cart and the free standing loading conveyor (fslc).The help of a second operator was indicated to have been necessary to pull out his hand.Related information received by getinge on 13th may, 2022 indicates that there was an injury which was described as bruising and a sore arm for some time and sick leave.There was no confirmed information if any medical intervention was required.The hospital service manager suspected that an ice pack was needed after the event, however the information could not be confirmed.Based on the information obtained, it appears there were no serious consequences.We were able to establish that this is one of several reportable customer product complaint related to an allegation of injury or harm while handling the automatic system used with washer disinfectors reported, within the last 5 years.The review did not provide any signals that would warrant further analysis.Taking into the consideration all information available it was determined by the subject matter expert from the manufacturing site that the most likely root cause of the event was related with a user error.The user manual describes that the machine should be stopped when the machine working area is entered.The operator is to pay attention and be careful with the machine¿s moving parts.The working area is also described as a risk zone and it is marked out to the user by the yellow/black markings as additional warnings for operators.The unit is also marked with warning symbols to indicate risk zone.Nevertheless, in this specific event, the operator entered the machine's working area, most probably not following mentioned warnings and it directly resulted in the reported situation.At the time of the event occurrence the unit was directly involved.However, we have no evidence that would allow to confirm that the unit failed to meet its specifications as the device was working as intended and no technical deficiency was reported.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.

Event Description

Manufacturer reference number: (b)(4).

• 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: 14335883
• MDR Text Key: 299848865
• Report Number: 9616031-2022-00009
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other