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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 8666
Device Problems Chemical Problem (2893); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by the manufacturing site.Device not returned to the manufacturer.
 
Event Description
On (b)(6) 2020 getinge became aware of an issue with one of the washer - disinfectors: 8666.The initially received customer allegation was pointing to the door issues.While troubleshooting, the technician noticed also another issue related to enzyme wand.It was not dipped in the detergent, but floating freely in the bottle.And this situation could have resulted in detergent being not dispense properly.We were not informed about any adverse consequences related to this issue, however we decided to report this complaint in abundance of caution and based on the potential.
 
Event Description
Manufacturer reference number (b)(4).
 
Manufacturer Narrative
When reviewing reportable events for this type of issues we were able to find total of 4 reportable complaints for mixed detergents on 86-series devices, reported to company¿s complaint handling system within last 5 years.When the event occurred, the device likely did not meet its specification as due to the small amount of detergent pump during the cycle, the cleaning and disinfecting process could have been affected.There was however no actual technical malfunction found within the main device.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2000, type 8666 washer disinfector.During the investigation course, we were able to establish that the detergent wand was not dipped in the detergent, but floating freely in the bottle.This happened due as an effect of user changing the detergent container to a bigger one, which was not compatible with the old wand.The technician, who detected the issue was able to solve the problem by changing the want to the longer one.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.
 
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Brand Name
86-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
ljungadalsgatan 11
vaxjo
MDR Report Key9725566
MDR Text Key198538407
Report Number9616031-2020-00007
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/24/2020
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 Operator No Information
Device Model Number8666
Device Catalogue NumberS-8666913-CTOM
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/22/2020
Initial Date FDA Received02/19/2020
Supplement Dates Manufacturer Received03/18/2020
Supplement Dates FDA Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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