MAUDE Adverse Event Report: GETINGE DISINFECTION AB CM320-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number CM320-4

Device Problem Device Fell (4014)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

On august 15th, 2023 getinge received information about event which was related to the getinge returned conveyor (rc 2.0).During the event the affected device cooperated with one of two cm320-series washer disinfectors.It was not possible to determine which exact washer disinfector was involved in this particular incident.The reported issue is related to rack falling to the ground from the return conveyor (rc 2.0).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 would warrant further scrutiny.The customer allegation was that the one of the baskets was stuck down.As it was stated, rack fell from the conveyor.The getinge service technician visited the site and investigated the device.The stop pin assembly was removed and lubricated.The shaft responsible for pushes stop pin to lower position was adjusted.The device was returned for use in a fully operational condition.The issue was consulted with the subject matter expert from the manufacturing site.As a result of the performed investigation, it has been determined that the stop pin failed.It is related to the stop pin assembly issue.It was established that when the event occurred, the affected device did not meet its specification as a malfunction of the pin occurred and led to the situation that the rack fell.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.The issue has not caused or contributed to any serious injury or worse, however we report the event based on the potential of serious injury if the situation was to reoccur.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

• Brand Name: CM320-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: tina evancho ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 18676128
• MDR Text Key: 335013688
• Report Number: 9616031-2024-00007
• 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
• Report Date: 02/09/2024

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: CM320-4
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose