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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB CM320-SERIES; DISINFECTOR, MEDICAL DEVICES

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GETINGE DISINFECTION AB CM320-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number CM320-4
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by the manufacturing site.Device not returnd to the manufacturer.
 
Event Description
On (b)(6) 2020 getinge became aware of an issue with one of the washer-disinfectors ¿ cm320.As it was stated, customer noticed a smoke rising from the device.He found the machine electrical parts burned out and some of devices¿ components melted inside the chamber.We have no information about any adverse outcome regarding the event, however we decided to report the complaint based on the potential of harm if the issue is to reoccur.
 
Manufacturer Narrative
When reviewing previous reportable events, we were able to establish that the event is a single, isolated one on the cm320-series devices when the significant overheating occurred, in the last 5 years.Following information provided in the complaint record, the device involved was a cm320-4 washer disinfector with the serial number (b)(6).The unit was manufactured on 23th march, 2016.Last maintenance was performed on 10th september 2017.Since the warranty expired, the device was not under getinge service agreement.Reviewing the photographic evidence that was provided to us and the information collected regarding the case, the subject matter expert (sme) at the manufacturing site has established 2 probable root causes of the overheating.In their estimation the first probable root cause of the device overheating could come from external sources.It is possible that incoming installation supply for the machine could have been faulty and that could have caused the overheating of the device.This is considered the most and likely cause regarding any electrical issues - especially overheating - when looking at the data in this case.Since the machine was idling, it would require some sort of fluctuation in the system to cause the overheating, which would most likely come from the external power supply.The second probable root cause was established as the overheating occurred from electrical components due to the humidity coming from detergent leakage.Leaking detergent could cause the moisture on electrical components and that could lead to the short circuit and in result to the overheating.The likely source of the leakage would have come from the detergent hoses, which should have been checked regularly and replaced as required by instruction of maintenance.As per the standard en-61010 the electrical connections inside the machine have implemented protection against spread of fire in case of sort circuit.Therefore, the internal parts of the device were not burned, but melted and charred from overheating.The possible root causes given by the manufacturer are based on the available information, however, we conclude that the exact root cause of the issue is still impossible to define.The probable root causes were defined as lack of preventive maintenance including detergent dosing parts check and replacement of faulty parts, which could have caused the leak on the electric components and short circuit in the result or, what is more probable, the overheating was caused by the facility power supply issues.It was established that when the event occurred, the affected device did not meet its specification.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.The getinge product was directly involved with the reported incident.The problem has been resolved by replacement of the affected parts.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
 
Event Description
Manufacturer reference number (b)(4).
 
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Brand Name
CM320-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
ljungadalsgatan 11
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MDR Report Key10033122
MDR Text Key200456935
Report Number9616031-2020-00018
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,foreig
Type of Report Initial,Followup
Report Date 05/07/2020
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 NumberCM320-4
Device Catalogue NumberCM320WUWD-CTOM
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/04/2020
Initial Date FDA Received05/07/2020
Supplement Dates Manufacturer Received02/09/2021
Supplement Dates FDA Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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