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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 Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2023
Event Type  malfunction  
Event Description
On (b)(6) 2023 getinge became aware of an issue with the 88-series washer disinfector with the model name:88-5.As it was stated, the washer caught fire during cycle.It was confirmed that a fire alarm started and the floor level was evacuated.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.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.
 
Event Description
Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
On october 26th, 2023 getinge became aware of an issue with the 88-series washer disinfector with the model name: 88-5 and serial number: (b)(6).The unit was manufactured on 1st november 2016 and installed on 4th september 2017.As it was stated, the washer has been overheated and triggered a fire alarm during its operating cycle.It was confirmed that the floor level was evacuated.During investigation it was established that washer overheated due to lack of circulation water in manifold.The most probable reason was related with malfunctioned relay, which was responsible of circulation pump did not work.The in-depth analysis of the relay failure could not be performed because it was not possible to return the part.The heating elements became overheated because there was no water circulation in the manifold, causing parts of the heating elements to be exposed to air instead of being submerged in water.This led to a rapid increase in temperature without activating the low circulation pressure alarm, which should have cut off the power supply to the heating elements.The investigation into why the low circulation pressure alarm did not activate revealed two possible factors.Firstly, it was discovered that the low pressure alarm was incorrectly set at 10 kpa instead of 20 kpa, which prevented it from activating during the incident.It had been altered by someone with authorized access to the p-parameters (process-critical configurations) without permission.Secondly, the pressure sensor showed the wrong value of 11.5 kpa instead of 0 kpa in standby phase.However, further investigation of the failed sensor was not possible as it could not be returned.Service technician, who was responsible for changing parameters and employees who worked with him have been briefed and warned against changing its parameters without seeking permission from the ssu service manager.Trend review of customer product complaints with the same issue involved on 88-series devices reported within the last 5 years was performed but did not provide any signals that triggered further scrutiny.When the incident occurred, the product was directly involved.The device did not meet its specification.The device was not being used for treatment or diagnosis of the patient.There was no injury reported until date, nevertheless we decided to report the issue based on the potential as this kind of malfunction could lead to serious injury.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
88-SERIES
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 Key18037297
MDR Text Key326905964
Report Number9616031-2023-00025
Device Sequence Number1
Product Code MEC
UDI-Device Identifier07340153700109
UDI-Public(01)07340153700109
Combination Product (y/n)N
Reporter Country CodeSN
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,Followup
Report Date 10/31/2023
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 Number88-5
Device Catalogue Number88-303-CTOM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/26/2023
Initial Date FDA Received10/31/2023
Supplement Dates Manufacturer Received08/07/2024
Supplement Dates FDA Received08/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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