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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES WASHER DISINFECTOR; DISINFECTOR, MEDICAL DEVICES

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GETINGE DISINFECTION AB 86-SERIES WASHER DISINFECTOR; 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 01/15/2024
Event Type  malfunction  
Event Description
On january 16, 2024 getinge became aware of an issue with a loading trolley with a serial number: (b)(6), which was used with one of three 86-series washer-disinfectors with serial numbers: (b)(6).A customer allegation was that the trolley is missing stopper.Getinge technician visited site and was informed that the trolley had been pushed onto the loader incorrectly and had fallen on the floor snapping of one of the arms on the carrier.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 trolley falling to the ground may result in a serious injury if the situation was to reoccur.
 
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 WASHER DISINFECTOR
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 Key18666310
MDR Text Key334845821
Report Number9616031-2024-00004
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeAS
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 02/08/2024
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
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/16/2024
Initial Date FDA Received02/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/05/2021
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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