MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z.O.O. ES60

Model Number ES 60

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is under manufacturer's analysis.

Event Description

On (b)(6) 2018 we became aware of an incident with boiler es60 which was connected to 233hc device.As it was stated by technician, the sparks and burning smell was coming from boiler.We decided to report the issue in abundance of caution, although the boiler is not a medical device itself but is connected to medical device and could be considered as a system, based on the potential of overheating of the device.

Manufacturer Narrative

This report is being filed under exemption e2017051 by the manufacturer getinge ic production poland sp.Z.O.O, (registration no.3012068831) on behalf of the importer getinge group logistics america, llc, (registration no. 3012092534).When reviewing reportable events for this type of issues we were able to establish that received incident is the first one registered in getinge complaint handling system for stand-alone type of boiler, model number es60.The issue is considered to be a single, isolated event.On (b)(6) 2018 we became aware of an incident with boiler es60 connected to 233hc sterilizer.As it was stated by technician, the sparks and burning smell was coming from the boiler.No adverse outcome was reported.Although the boiler itself is not registered as a medical device it is connected to a medical device and could be considered as part of a medical device system.Having this in mind, we decided to report this complaint in abundance of caution and based on the potential of overheating of the device.After the issue occurrence, the device has been inspected by getinge technician and described as unrepairable, thus excluded from the service.The boiler involved in the event was identified as es60 stand-alone type of boiler manufactured by sussman, with serial number esm1131963-016.Those type of devices, although not manufactured by getinge are sold by our company as a complementary unit and connected via pipe to the getinge labeled sterilizer or washer.Based on the information collected to date and as a result of performed investigation it has been confirmed that when the device is not well maintained, the heating elements can leak water into electrical cabinet, resulting in the situation as described within this incident.According to sussman electrical boilers es&hu installation, operation and maintenance manual pur 101137 rev 5.18 page 13 the internal wiring should be inspected once a month and if any wire shows signs of damage, it should be replaced.What is more, all heating elements mounting bolts should be checked and tightened to a torque of 22 ft.-lbs.If there are signs of steam leaks, gasket should be replaced.All elements should be also checked for leak once a month and if any part is damaged it should be replaced.In summary, when the event occurred, the boiler device likely did not meet its specification and it contributed to event.Upon the event occurrence the device was not being used for patient treatment.We believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.Additionally, the information regarding the incident has been forwarded to the original manufacturer of the boiler device.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: ES60
• Type of Device: ES60
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z.O.O.; szkolna 30; plewiska, 62-06 4; PL 62-064
• MDR Report Key: 7905518
• MDR Text Key: 121583702
• Report Number: 3012068831-2018-00011
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 09/25/2018,10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ES 60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2018
• Distributor Facility Aware Date: 08/28/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1