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

Model Number 8668

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

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 (b)(6) 2021 getinge became aware of an event related to the 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 broken.As a consequence, the washing rack almost fell.After reporting the event, the repair was performed and the trolley was returned to the service in fully operational state.There was no information provided about adverse outcome for this occurrence.Nevertheless, the fully loaded washing rack 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.

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 reference number: (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On november 24th, 2021, getinge became aware of an issue related to smart trolley used together with washer disinfector model 8668.The washer was manufactured on april 15th, 2019 with serial number (b)(6) and udi number (b)(4).The last preventive maintenance on the device and equipment was performed in september 2021.As it was provided in the complaint record the cart loaded with instruments, which was placed on the transfer trolley almost fell on the ground due to malfunction of stop pin mechanism.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 manual 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 malfunctioning and it consequently led to the situation when rack almost fell of the trolley.A getinge service technician visited the customer site, resolved the problem by replacing the stop pin mechanism 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.

• 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: 13072871
• MDR Text Key: 284820514
• Report Number: 9616031-2021-00041
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8668
• Device Catalogue Number: S-86682003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1