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

Device Problems Corroded (1131); Device Fell (4014)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On october 24, 2023 getinge received an information about the event, which was related to the getinge freestanding loading and unloading conveyor (fslc/fsuc 2.0) used with the 86-series washer disinfector.As it was stated, the washing rack fell from the unloader.The cleaning rack did not stop at the end of the unloader and fell as the loading trolley was not docked.There was no injury reported.During the getinge technician inspection of the device it was detected that the chain of the docking port was rusted.Water dripped on a chain despite a protective cover, which is installed to prevent water from directly splashing on the chain.The technician removed some of the rust using teflon-based lubricating spray, and it was confirmed that the lubricant allowed for smooth lifting and lowering of the chain.In order to stop the corrosion it is recommended to replace the part.The device was tested and returned to work in operational state.The customer was instructed to remove water from the vat and tray before docking the loading trolley and to ensure that water does not accumulate when loading items on the washing rack.So far, we have not been informed about any injury as a consequence of the reported issue, however we decided to report this issue based on the potential for a serious injury if the situation was to reoccur.

• Brand Name: 86-SERIES WASHER DISINFECTOR
• 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: 18020028
• MDR Text Key: 326685725
• Report Number: 9616031-2023-00024
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1