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

Model Number CM320-4

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 06/23/2022

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 june23rd, 2022 getinge received an information related to the cm320-series washer disinfector.As it was stated the cart drove past the end point of the conveyor due to the pin getting stuck in the lower position.The cart was hanging over the edge and therefore could fell onto the floor.There was no injury or damage reported, however we decided to report the issue based on a potential as the rack that fell on the ground could bring a hazardous situation for the operator and lead to serious body injury if the situation was to reoccur.After the event, the unit was evaluated and after troubleshooting the device was returned to use in fully operational state.

Event Description

Manuafacturer's reference number: (b)(4).

Manufacturer Narrative

On 23rd june, 2022 getinge became aware about an event with a washer disinfector from cm320-series that took place on the same day.The involved device was identified to carry serial number: (b)(6) and catalog number: cm320wuwd-ctom.Manufacture date of the device is 27th october, 2015.The mentioned unit is under getinge maintenance agreement and as it was confirmed that the last service was carried out on 26th may, 2022.The reported issue is related to cart nearly falling from the cm320-series washer.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 security.As it was stated by the getinge service technician, who visited the site after the event occurrence, the stop pin was intermittently getting stuck down due to low spring pressure.This led to the hazardous situation where the cart almost fell off from the unloader.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 spring and the stop pins failed.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 cart nearly fell and in this way the device contributed to reportable event.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.We are not aware if the described issue 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.The issue is still evaluating and 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.

• 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: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 14953529
• MDR Text Key: 303097676
• Report Number: 9616031-2022-00017
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CM320-4
• Device Catalogue Number: CM320WUWD-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1