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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 90-SERIES; DISINFECTOR, MEDICAL DEVICES

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GETINGE DISINFECTION AB 90-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 9027
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site.Device not returned to manufacturer.
 
Event Description
On (b)(6) 2020 getinge became aware with issue where the pump was leaking.According to the information provided by the customer unit did not display any alarm codes.During inspection at the customer site, the getinge representative confirmed correct error appearance and that the user was acknowledging the alarm and repeatedly running the unit, without having the source of the leak fixed.Fortunately no adverse consequences was reported.Nevertheless, we decided to report this issue based on potential risk related to loads being process with the error condition being ignored by the user, what could result in incorrectly processed loads being used.
 
Event Description
Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
The purpose of this submission is to provide a correction of manufacture date#.This is based on the result of an internal review noting the initial report was incorrectly submitted stating another manufacture date.#h4: previous manufacture date#: 2015-04-23, corrected manufacture date#: 2015-04-21.
 
Event Description
Manufacturer reference number (b)(6).
 
Manufacturer Narrative
On 1st july, 2020 getinge received a customer allegation regarding the leaking of a pump that is attached to the washer disinfector.The leaking is alleged to have caused water entering the mechanical / device room due to this issue.The unit was reported as not showing error codes.During the inspection at the customer site however, the getinge representative did confirm that the error had been displayed on the device and that the operator ran the machine despite the alarm condition.The customer was informed to not use the device until the source of the leak, in this case established as a lack of circulation pump plug, is fixed by the qualified personnel.Upon next arrival at the customer site, the getinge technician confirmed that the unit was not excluded from use and, since the last service visit, the customer attempted to complete disinfection cycles in it and the customer attempted to repair it by themselves, a repair which the customer not trained for.The affected device is washer disinfector 9027 manufactured on 21st april, 2015.We were able to establish that this issue is the 2nd reportable customer product complaint, within last 5 years, related to the situation where the user acknowledged the alarm displayed on the device and yet repeated ran the use cycle.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death, to the best of our knowledge.When the event occurred, the washer-disinfector did not meet its specification as a leakage occurred.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment but it certainly played a role in the reported event.During the investigation course we were able to establish, that the alarm codes displayed on the device as per the design and adequate to the situation ¿ showing a leakage from the circulation pump.As it was established, the circulation pump was leaking due to a missing plug, which most likely has been disassembled by an unauthorized person.The root cause of this reported event was identified as a user error; since the user did not follow the recommendation and continued to use the device, even although an error was discovered during the cycle.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 and do not propose any further action at this time.
 
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Brand Name
90-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
ljungadalsgatan 11
vaxjo
MDR Report Key10332014
MDR Text Key202213935
Report Number9616031-2020-00026
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,user f
Type of Report Initial,Followup,Followup
Report Date 11/03/2020
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 Health Professional
Device Model Number9027
Device Catalogue Number9027-002
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/01/2020
Initial Date FDA Received07/28/2020
Supplement Dates Manufacturer Received08/18/2020
10/07/2020
Supplement Dates FDA Received09/11/2020
11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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