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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 46-SERIES; DISINFECTOR, MEDICAL DEVICES
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GETINGE DISINFECTION AB 46-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 46-5
Device Problem Unintended Electrical Shock (4018)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2023
Event Type  malfunction  
Event Description
On march 10, 2023 getinge became aware of an issue with the 46-series washer disinfector.As it was stated, the operator od the device felt small electrical shock while touching the drain pump.The machine was checked by the getinge technician, and water drops were observed in the electrical line.All electrical cables and connectors were cleaned with dry cloth and air.The machine was checked with load, and it was confirmed that the machine is in working condition.It was stated that the event did not lead to any injury, however we decided to report this case based on the potential for a serious injury if the situation was to reoccur.
 
Manufacturer Narrative
Additional information will be provided following the conlusion of the investigation.Device not returned to the manufacturer.
 
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Brand Name
46-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 Key16571465
MDR Text Key311598138
Report Number9616031-2023-00010
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeIN
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 03/20/2023
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 Number46-5
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/10/2023
Initial Date FDA Received03/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/03/2007
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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