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

Model Number	8668
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.
Event or Problem Description
On 17th february, 2022 getinge became aware of an event related to the manual trolley that was used with the 86-series washer disinfector with the model name 8668.As it was stated the trolley stop part that prevents the washing rack from falling of the trolley was missing.As a consequence, the shelf fell.There was no injury or damage reported.Nevertheless, the fully loaded shelf falling on the ground 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.
Event or Problem Description
Manufacturer reference number: (b)(4).
Additional Manufacturer Narrative
On 17th february, 2022 getinge became aware of an issue related to smart trolley used together with washer disinfector model 8668.The washer disinfector was manufactured on 28th january, 2021 with serial number (b)(6) and udi number (b)(4).As it was stated the trolley stop part that prevents the washing rack from falling of the trolley was missing.As a consequence, the shelf fell.There was no injury or damage reported.Nevertheless, the fully loaded shelf falling on the ground 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 review of reportable events registered for accessories used with getinge disinfection ab devices reported to company¿s complaint handling system within last 5 years was performed.It revealed that the complaint is one of several reported cases with the allegation about cart, rack or instruments falling or nearly falling from the smart trolley due to the various reasons.However, compared to the number of devices available on the market according to install base, failure rate is very low.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment or diagnosis.During the investigation, it was found that in the past the reported scenario has led to serious injury.It was established that when the event occurred, the manual trolley, which was used as a system with washer disinfector 8668 did not meet its specification.During the device evaluation it was identified that the stop pin installed on the trolley was missing and it consequently led to the situation when shelf fell.A getinge service technician visited the customer site, resolved the problem and returned the device for usage, which is now fully operational.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.
Additional 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 or Problem Description
Manufacturer reference number: (b)(4).

• Brand Name: 86-SERIES
• Common Device Name: 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: 13577862
• Report Number: 9616031-2022-00005
• Device Sequence Number: 5644337
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2022

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
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 06/14/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/16/2022; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown