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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 Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2022
Event Type  malfunction  
Event Description
On november 11th, 2022 getinge received an information about the event, which was related to the 86-series washer disinfector with the model name 8668.As it was stated, the safety lock of the trolley of the washing machine fell off.As a result a cleaning rack fell on the ground.The safety lock was reinforced by the getinge technician and the device and the trolley were returned for use in a fully operational condition.There was no allegation about any injury or damage, 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 was to reoccur.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.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
vaxjo
Manufacturer (Section G)
GETINGE DISINFECTION AB
ljungadalsgatan 11
vaxjo
Manufacturer Contact
dennis genito
ljungadalsgatan 11
vaxjo 
MDR Report Key15868152
MDR Text Key304346096
Report Number9616031-2022-00027
Device Sequence Number1
Product Code MEC
UDI-Device Identifier07340153700277
UDI-Public(01)07340153700277
Combination Product (y/n)N
Reporter Country CodeCH
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 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8668
Device Catalogue NumberS-86682003-CTOM
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/11/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/02/2021
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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