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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 Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2023
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.
 
Event Description
On (b)(6) 2023, getinge became aware of an issue with the 86-series washer disinfector with the model name: 8668.As it was stated, the customer notified of a fire in the sterile processing department of their outpatient clinic.The equipment that caused the incident was identified, as the device, which is reported herein.Additionally, damage to adjacent equipment was reported.It was confirmed that a fire alarm started at the facility and an evacuation was carried out.We have not been informed about any injuries or delays in life-saving procedures as a result of this event.Getinge has not been allowed to access the facility and inspect the equipment so far.There is no information about any adverse outcome regarding the event, however we have decided to report the issue based on the potential of harm if the issue was to reoccur.
 
Event Description
Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
On april 30th, 2023, getinge became aware of an issue with the 86-series washer disinfector with the model name: 8668 and the serial number: (b)(6).The unit was manufactured on 18th march, 2013 and installed on (b)(6) 2013 as it was stated, the customer notified of a fire in the sterile processing department of their outpatient clinic.The equipment that caused the incident was identified, as the device, which is reported herein.Unfortunately, further details are unavailable at this time, making it impossible to define the case.It was established that the getinge product was directly involved with the reported event and not meet its specification.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that triggered further scrutiny.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment or diagnosis.We believe that devices in the market are performing correctly overall.Given the circumstances and the fact that there is no apparent trend in complaints of this nature, we shall continue to monitor for any further events of this nature.
 
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Brand Name
86-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 Key16909977
MDR Text Key314975527
Report Number9616031-2023-00015
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/11/2023
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 Number8668
Device Catalogue NumberS-86682003-CTOM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/30/2023
Initial Date FDA Received05/11/2023
Supplement Dates Manufacturer Received09/25/2024
Supplement Dates FDA Received09/27/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/18/2013
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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