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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES
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GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 8668
Device Problem Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
Event Type  malfunction  
Event Description
On february 29, 2024 getinge became aware of an issue related to the automation loading system with the model name: ags 2.0.The getinge ags 2.0 is not registered as a medical device, however upon the situation occurrence it was used with the four medical devices - 86-series washer disinfectors with the model name: 8668.As it was stated, the rack almost fell on the floor.Gathered information allowed us to establish that device was restarted and it was returned to the service in full working condition.There was no allegation of injury however, we decided to report the issue based on a potential as a rack falling to the floor could bring a hazardous situation for the operator and lead to serious injury if the situation reoccurs.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.
 
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Brand Name
86-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
ljungadalsgatan 11
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Manufacturer (Section G)
GETINGE DISINFECTION AB
ljungadalsgatan 11
vaxjo
Manufacturer Contact
tina evancho
ljungadalsgatan 11
vaxjo 
MDR Report Key18884317
MDR Text Key337416965
Report Number9616031-2024-00012
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/12/2024
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 Number8668
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/29/2024
Initial Date FDA Received03/12/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/03/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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