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

Model Number	CM320
Medical Device Problem Code	Component Falling (1105)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).Additional information will be provided upon results of the investigation.
Event or Problem Description
On (b)(4) getinge became aware of an incident caused by one of the medical devices manufactured by getinge.From information provided by the customer after the washing process the wash cart from cm320 washer disinfector had been transferred on the unloading conveyor and moved to the clean side.The wash cart during the proper operation should stopped when reached end of the unloader.However in the case reported by the customer the wash cart overturned and fell down to the ground.Service technician who arrived on site reported that stop pin was broken.As a result of the event no injury has been reported.However we decided to report this case in abundance of caution.
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).The event is being investigated.Additional information will be provided upon results of the investigation.
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by the manufacturer (b)(4).The event is still being investigated by manufacturing site and currently the issue is consulted with the supplier.Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).Getinge received a customer complaint where, as stated, a cart fell of from the smart trolley.Please note that smart trolley itself is not a registered medical device, however the cm320 device is registered as a medical device system.The smart trolley is an accessory manufactured by an external supplier and labeled by getinge sterilizaton ab and it can be used with a wild range of devices.This issue has been escalated to the trolley's supplier.According to the information provided by the supplier all trolleys are checked after assembly with accordance to the proper protocol.Mentioned protocol included many steps of final inspection which are to be taken before the trolley is released further.It has been established that during final testing general functionality test of the trolley is performed however the retainer ring (circlip) is not checked specifically.It has been also established that there is a possibility that during loading/unloading procedure the circlip could loosen and this may not be noticed by the customer as it is located under the trolley.The circlip is an off-the shelf component.It not taking up any force in this application.Its only purpose is to keep the bolt in place.If the grove is correct and the circlip is correctly installed it simply cannot detach by itself.It is possible that the ring was not properly installed however complaint review did not show a trend of similar complaints.As a result, we cannot exclude ill-judged maintenance actions during the device lifetime.It has been established that when the event took place the device was likely not up to the manufacturer specification and it directly contributed to the outcomes of the event.It has been also established that when the event took place the device was not used for treatment or diagnosis.Given the circumstances and the fact that there is no trend observed for customer complaints with this failure mode, we shall continue to monitor further events of this nature.
Additional Manufacturer Narrative
The follow up report (mfr report # 9616031-2017-00026) is submitted due to the missing f/u 3 and it is submitted to correct the error in numbering.There is no new information regarding this case.The final report (3004147784-2017-000266) was sent on 25/06/2018.The date received by mfg is the date when the fda request was received (03.04.2025).
Event or Problem Description
Manufacturer's reference number tw: (b)(4).
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).Root cause analysis of the issue is still under investigation.Additional information will be provided following the conclusion of the investigation.

• Brand Name: CM320
• Common Device Name: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• Manufacturer Contact: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 6743450
• Report Number: 9616031-2017-00026
• Device Sequence Number: 822332
• Product Code: MEC
• UDI-Device Identifier: 07340153700215
• UDI-Public: 07340153700215
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/25/2018
• Report Date (Section F): 07/25/2017

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 Number: CM320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 06/29/2017; 06/29/2017; 04/03/2025
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 09/01/2017; 03/19/2018; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/25/2017