MAUDE Adverse Event Report: GETINGE SOURCING LLC GETINGE 433HC STEAM STERILIZER

Model Number 433HC

Device Problem Device Issue (2379)

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

Event Date 01/16/2016

Event Type  malfunction  

Manufacturer Narrative

When reviewing reportable events for the low level cut off board for steam boiler cas30c used in 433hc sterilizers, we were able to establish that this issue can be considered to be a single, isolated event.The product involved in the incident is an 433hc sterilizer, model 433hc, serial number (b)(4) which was manufactured on june 2012.The steam boiler cas30c with serial no (b)(4) was installed (b)(6) 2013 on a 433hc at (b)(6) and was in use for more than 2 years before the issue occurred on (b)(6) 2016.The device history record has been reviewed; no anomalies were recorded on the record at the time of manufacture.Inspection of the involved parts conducted by the getinge representative revealed that the failure most probably was related to a loose electrical 1/4" spade connection of wiring plugs into the top of level control board near transformer.This had caused electrical arcing and heat.We have established that the smoke was from a trace on the board overheating and melting the plastic board itself.No damage was done to components other than the board and its related wiring.Please note that all components are ul certified and also that the control board material meets ul 94 for flammability.The electrical arcing/heat was contained within a metal cabinet that was not compromised.Additionally the entire sterilizer plumbing and electrical components, including boiler, is within a stainless steel cabinet, accessible for service.Therefore in conclusion there would have been no harm to operator or service personnel other than the smoke.The connection could have been disturbed during other maintenance on the boiler: possibly the heating element gasket replacement one month earlier.However it is not possible to conclude on a root cause with the information we have been able to obtain, despite our best efforts.In summary, the device which played a role in this event was not being used for treatment or diagnosis at the time of issue occurrence, due to the device's intended use.The device did fail to meet its specifications and was directly involved with the reported incident.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time, other than alerting the technician that did the previous maintenance activities on the device.There have been no events where the described board failure has been related to injuries to date.Based on all information gathered we were able to conclude that although reported in the abundance of caution, the failure at hand is not likely to bring on any immediate risk for users.

Event Description

Customer complaint was received of a 433hc steam sterilizer emitting smoke.Customer stated that the fire department arrived to smoke in the sub-sterile room and smoke alarms sounding.No employees or patients were present at the time of the incident.There were no injuries reported and property damage was restricted to the low level cut off board and associated wiring contained within the integral steam boiler control box.

• Brand Name: GETINGE 433HC STEAM STERILIZER
• Type of Device: STEAM STERILIZER
• Manufacturer (Section D): GETINGE SOURCING LLC; 1777 east henrietta road; rochester NY 14623
• Manufacturer (Section G): GETINGE SOURCING LLC; 1777 east henrietta road; rochester NY 14623
• Manufacturer Contact: barb smith ; 1777 east henrietta road; rochester, NY ; 5852146049
• MDR Report Key: 5434343
• MDR Text Key: 38777588
• Report Number: 1314329-2016-00001
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/16/2016

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: Health Professional
• Device Model Number: 433HC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/16/2016
• Initial Date FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other