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

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).

• Brand Name: CM320-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 10033122
• MDR Text Key: 200456935
• Report Number: 9616031-2020-00018
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: CM320-4
• Device Catalogue Number: CM320WUWD-CTOM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1