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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES
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GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 88-5
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2024
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Event Description
On march 19th, 2024 getinge became aware of an issue with the 88-series washer disinfector with the model name: 88-5.As it was stated, the smoke came out from the device.It was confirmed that firefighters used fire extinguishers on the smoke coming from the machine.So far, we have not been informed about any serious injury as a consequence of reported issue, however we decided to report the issue in abundance of caution and based on the potential for serious injury if the situation was to reoccur.
 
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Brand Name
88-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
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Manufacturer (Section G)
GETINGE DISINFECTION AB
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Manufacturer Contact
tina evancho
ljungadalsgatan 11
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MDR Report Key18958471
MDR Text Key339139068
Report Number9616031-2024-00015
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeIT
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 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number88-5
Device Catalogue Number88-303-CTOM
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2014
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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