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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 91E-SERIES; DISINFECTOR, MEDICAL DEVICES

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GETINGE DISINFECTION AB 91E-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 9125E
Device Problem Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2024
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.
 
Event Description
On (b)(6) 2024 getinge became aware of an issue with 91e-series washer disinfector.A customer allegation was related to the door issue.As it was stated, load (a container) had fallen off the loading cart and obstructed the door.No getinge technician service visit was required.Machine returned to normal working condition.So far, we have not been informed about any adverse consequences of reported issue, however we decided to report the issue based on the potential as the load falling to the ground may result in a serious injury if the situation was to reoccur.
 
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Brand Name
91E-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
tina evancho
ljungadalsgatan 11
vaxjo 
MDR Report Key18612193
MDR Text Key334140494
Report Number9616031-2024-00002
Device Sequence Number1
Product Code MEC
UDI-Device Identifier07340153710047
UDI-Public(01)07340153710047
Combination Product (y/n)N
Reporter Country CodeCA
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 01/31/2024
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 Number9125E
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/19/2024
Initial Date FDA Received01/31/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2019
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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