MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O TORNADO; WASHER OF BODY WASTE RECEPTACLES

Model Number FD1810

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).The involved device was evaluated by the arjo representative and found unusable, hence it was removed from service.The investigations on-going and further information will be provided in the next report.

Event Description

Arjo was notified about an event with involvement of tornado flusher.It was reported that the device's steam generator started the fire, which burned the quick connect cable and all components around that part.No other part was damaged.The facility personnel used the extinguisher to stop the fire.

Manufacturer Narrative

The faulty device has been replaced with a new unit.The investigation including collection and analysis of information is still on-going and further update will be provided in the next report.

Manufacturer Narrative

Arjo was notified about an event with the involvement of tornado flusher.It was reported that a fire started in the device's steam generator, which burned the quick connect cable and all components around that part.The fire supposedly came from the steam generator because parts around this area were melted.It was determined that either the steam generator or the quick connect from the steam generator could be a source of fire as beside them no part in that area was electrical.No other part was damaged.The facility personnel used the extinguisher to stop the fire.No injury was reported.The involved device was evaluated by an arjo representative, it was found to be unusable and was removed from service.At the time of the visit and inspection, the steam generator was not installed in the device.Therefore, no further investigation of this assembly was possible.The faulty device has been replaced with a new unit.The device in question was under the arjo service contract.The last service of the device, before the event, was performed at the beginning of december 2019.During that inspection, the functional test was performed and no deviations were found.Based on product knowledge we have been able to define a few likely causes which could influence the event: 1) it is possible that the electric leak at the connector or cable occurred due to accumulated dust and/or humidity on the wire contacts or broken cable insulation causing overheating of plastic parts that in consequence resulted in fire initiation.Every plug connection is designed to be hermetic to separate it from environmental conditions however over time, it might loosen making space for water drops or dust.2) what is more, after water drops, it dries on wire contact and further precipitate may be left.The precipitate creates electrical insulation.Because of that, the resistance of the wire increases leading to its heat up while electricity conducting.It could cause the cable to burn.3) it is also possible that the temperature limiter, which should turn off the flusher when the temperature inside the steam generator is too high, was not functioning properly at the time of the incident- either not able to react fast enough to the rising temperature, or not reacting at all.The overheating of the steam generator might have initiated a fire.In this case, due to the steam generator not being available for evaluation it was not possible to identify and confirm the exact cause of the reported event.Based on the available information the fire could have been potentially caused by the overheating steam generator, but as stated above other possibilities should are considered possible such as that the ignition was caused by a short circuit in the area of the connector to the steam generator.The device was damaged in the area where the fire was noticed, hence no further conclusions could have been drawn in this case.Upon review of the device service history records no evidence of the steam generator replacement in the past was indicated, so it is considered likely that this assembly has not been replaced since manufacturing.It should be underlined that tornado flusher was designed and verified according to requirements of iec 61010-1:2010/amd1:2016, which means that the enclosure was made of materials having a flammability classification of v-1 or better and its components (such as a steam generator) are equipped with over-temperature protection devices.To ensure the safety of our products the tornado user manual (6001314502 rev.A) includes the following warning: ¿if the machine has not been used for 72 hours, the steam generator and circulation pump need to be drained according to iso 15883.¿ in summary, according to the gathered information the involved tornado flusher was most probably used for accessories cleaning, when the event occurred.Based on the performed evaluation of the device, its components were burnt and was in overall unusable condition.As per the collected information, no injury or health consequences were reported to be a result of this event.This complaint was decided to be reported to the regulatory authorities due to an indication of fire occurrence.

• Brand Name: TORNADO
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O; ul. szkolna 30, plewiska; plewiska PL-62 064; PL PL-62064
• MDR Report Key: 9615562
• MDR Text Key: 175835395
• Report Number: 3007420694-2020-00009
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FD1810
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other