MAUDE Adverse Event Report: GETINGE DISINFECTION AB WD15 CLARO; MEC

Model Number	GE15
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
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 30th august 2017 getinge became aware of an incident which was a result of overheated claro device.As it was stated overheated elements of washer disinfector caused smoke emission which activated fire alarm.Alarm activation resulted in delays in surgeries planned at customer site.No injury has been reported due to described situation.However we decided to report this case in abundance of caution.
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by (b)(4).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 getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).The event is still being investigated.Additional information will be provided upon results of the investigation.
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by (b)(4).Getinge received customer complaint where, as stated, during the process of the washer disinfector the heater became red and a lot of smoke was noticed.The smoke caused activation of the fire alarm and - as a result - delay in the performed procedure.No trend for this particular issue has been observed.User manual for getinge wd15 claro (6001396602, rev.E) include information about proper maintenance of the device and for example it clearly states that the wash chamber should be kept free of limescale deposits and if the washer-disinfector is used without automatic descaling for incoming water, the heating element must be checked regularly for any limescale deposits.It has been established that the malfunctioned device which played role in the investigated herein issue has been not serviced by getinge since the september 2015, rather this was indicated to have been performed by the in-house technical service of the facility.Based on all information provided so far and included in the user manual we can only point to a most likely root cause to be connected with the lack of proper maintenance, however as no information about the device nor its history has been provided it is impossible to define a more precise root cause of the failure.In summary, when the issue took place the device was not used for treatment or diagnosis and it was not up manufacturer specification.It has been established that the device contributed to the outcomes of the event, however no injury has been reported due to described malfunction.Based on all information we decided to report this case in abundance of caution.

• Brand Name: WD15 CLARO
• Common Device Name: MEC
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• MDR Report Key: 6875170
• Report Number: 9616031-2017-00028
• Device Sequence Number: 1297724
• Product Code: MEC
• UDI-Device Identifier: 07340153700239
• UDI-Public: 07340153700239
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2018
• Report Date (Section F): 09/19/2017

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
• Operator of Device: No Information
• Device Model Number: GE15
• Device Catalogue Number: GE15-003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017; 08/30/2017; 08/30/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/19/2017; 11/28/2017; 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 09/19/2017