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

Model Number	CM320-2
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with the cm320-series washer disinfector, with the model name cm320-2.As it was stated cart fell off.So far, we have not been informed about any serious injury as a consequence of reported issue, however we decided to report the issue in abundance of caution and based on the potential for serious injury if the situation was to reoccur.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
On october 23rd, 2023 getinge became aware of an issue with the cm320-series washer disinfector, with the model name cm320-2 and serial number (b)(6).The washer disinfector was manufactured on 21st march, 2017 and installed in the facility on 30th november, 2017.As it was stated the cart fell of from the conveyor on the floor, because the shuttle (device, which is responsible for transfer the cart to washer chamber) did not receive the cart and the stop pin did not go up to allow the cart to stop.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.Based on the investigation and information provided by the subject matter expert, the device was found to be working according to specification and the issue could not be recreated.The device has been restarted and the problem did not occur again.Unfortunately, the exact root cause of the problem cannot be identified without a more detailed description which is not available.When the incident occurred, the product was directly involved.The device did not meet its specification.The device was not being used for treatment or diagnosis of the patient.There was no injury reported until date, nevertheless we decided to report the issue based on the potential as this kind of malfunction could lead to serious injury.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.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: CM320-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: tina evancho ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 18063075
• Report Number: 9616031-2023-00026
• Device Sequence Number: 7427551
• Product Code: MEC
• UDI-Device Identifier: 07340153700185
• UDI-Public: (01)07340153700185
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 11/02/2023

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: CM320-2
• Device Catalogue Number: CM320WD-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: 10/23/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown