MAUDE Adverse Event Report: GETINGE DISINFECTION AB 90-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 9027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.

Event Description

On 13th october, 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 9027.As it was reported by the customer, there was water leak from the door.The operator slipped and fell in front of the clean side of cart washer, right by the door.The getinge service technician visited the site, evaluated the device and found no malfunction related to the unit that could have led to the alleged scenario.Information available until the date states that the injured employee was in the emergency room.The incident report does not provide any further information about the injury, therefore we cannot classify the health effect.Based on the available information, we decided to report the complaint in abundance of caution as we cannot confirm that similar event would not contributed to the serious injury if recur.

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 also to provide an additional information in the #b5.Describe event or problem and the correction in the #h4.Device manufacture date previous provided #b5.Describe event or problem: on 13th october, 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 9027.As it was reported by the customer, there was water leak from the door.The operator slipped and fell in front of the clean side of cart washer, right by the door.The getinge service technician visited the site, evaluated the device and found no malfunction related to the unit that could have led to the alleged scenario.Information available until the date states that the injured employee was in the emergency room.The incident report does not provide any further information about the injury, therefore we cannot classify the health effect.Based on the available information, we decided to report the complaint in abundance of caution as we cannot confirm that similar event would not contributed to the serious injury if recur.Currently provided #b5.Describe event or problem: on 13th october, 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 9027.As it was reported by the customer, there was water leak from the door.The operator slipped and fell in front of the clean side of cart washer, right by the door.The getinge service technician visited the site, evaluated the device and found no malfunction related to the unit that could have led to the alleged scenario.Information available until the date states that the injured employee was in the emergency room.The incident report does not provide any further information about the injury, therefore we cannot classify the health effect.Based on the available information, we decided to report the complaint in abundance of caution as we cannot confirm that similar event would not contributed to the serious injury if recur.On 10th november, 2022 we received confirmation that the person who slipped and fell was not seriously injured and returned to work.Previous provided #h4.Device manufacture date: 2011-01-24; corrected #h4.Device manufacture date: 2010-12-20.

Event Description

On 13th october, 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 9027.As it was reported by the customer, there was water leak from the door.The operator slipped and fell in front of the clean side of cart washer, right by the door.The getinge service technician visited the site, evaluated the device and found no malfunction related to the unit that could have led to the alleged scenario.Information available until the date states that the injured employee was in the emergency room.The incident report does not provide any further information about the injury, therefore we cannot classify the health effect.Based on the available information, we decided to report the complaint in abundance of caution as we cannot confirm that similar event would not contributed to the serious injury if recur.On 10th november, 2022 we received confirmation that the person who slipped and fell was not seriously injured and returned to work.Manufacturer`s reference number: (b)(4).

Manufacturer Narrative

On 13th october, 2022 getinge became aware of an issue with one of the washer-disinfectors with 90-series washer disinfector with model name: 9027 and the serial number (b)(6).The unit was manufactured on 20th december, 2010 and installed on july , 2011.In the alleged event, the person slipped and fall of the operator on the wet floor due to the water leakage.It was stated that the getinge service technician visited the site, evaluated the device nevertheless no malfunction related to the unit has been found that could have led to the alleged scenario.Nevertheless, we decided to report the complaint in abundance of caution as we cannot confirm that similar event would not contribute to the serious injury if reoccur.A root cause analysis was performed by subject matter expert.As no evidence of leakage was found on the device and the alleged issue could not be recreated, therefore, the root cause cannot be confirmed.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that triggered further scrutiny.It was established that the getinge product was directly involved with the reported event.Nevertheless, we could not confirm that the washer disinfector failed to meet its specifications as a reported malfunction was not observed during the visit.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment or diagnosis.We believe that devices in the market are performing correctly overall.Given the circumstances and the fact that there is no apparent trend in complaints of this nature, we shall continue to monitor for any further events of this nature.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: 90-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: 15625209
• MDR Text Key: 301948091
• Report Number: 9616031-2022-00021
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 9027
• Device Catalogue Number: 9127E-001-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/10/2022; 10/06/2023
• Supplement Dates FDA Received: 12/05/2022; 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female