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U.S. Department of Health and Human Services

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

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GETINGE DISINFECTION AB CM320-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
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.
 
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Brand Name
CM320-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
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Manufacturer (Section G)
GETINGE DISINFECTION AB
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Manufacturer Contact
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MDR Report Key18676128
MDR Text Key335013688
Report Number9616031-2024-00007
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberCM320-4
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/31/2023
Initial Date FDA Received02/09/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/06/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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