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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. AMIGO; WASHER OF BODY WASTE RECEPTACLES
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ARJOHUNTLEIGH POLSKA SP. Z O.O. AMIGO; WASHER OF BODY WASTE RECEPTACLES Back to Search Results
Model Number SXXO301ACON6025
Device Problem Failure to Auto Stop (2938)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
The device was removed from use, evaluated by the technician.According to the results of inspection, it was found that the electrical contactor had stuck on open causing the current to still flow and resulting in steam was still entering the washer's chamber.The defective part was replaced.
 
Event Description
Arjo was notified about an incident with involvement of amigo washer.It was reported that after the washing cycle finished and user attempted to remove items from the device's chamber, the steam was still coming out of the nozzles.According to the customer's allegation, the user almost burned their hands, but no injury occurred.
 
Manufacturer Narrative
Arjo was notified about an incident with involvement of amigo washer.It was reported that after the washing cycle finished and user attempted to remove items from the device's chamber, the steam was still coming out of the nozzles.According to the customer's allegation, the user almost burned their hands, but no injury occurred.The hospitals personnel turned off the power on the safety switch and informed arjo about the issue.The device was taken out of use and evaluated by the arjo representative.According to the results of inspection, it was found that the electrical contactor had stuck on open (turned on) position causing the electrical current to still flow and resulting in steam still entering the washer's chamber.No error code was displayed on the device.The defective part was replaced, which rectified the issue.Amigo instructions for use provide information for correct and safe usage of the device, which also refer to the reported situation e.G.: ¿the machine must only be handled by authorized personnel.Personnel must also receive regular training.¿ ¿exercise caution when using the machine, as it uses hot water and possibly steam.¿ during normal functioning of the device, when the program is complete the green indicator lights up and the door slightly opens.Moreover, the device displays u7 error code which warns user that the goods inside chamber are still of high temperature.According to the ifu, the machine must always be equipped with a separate isolator switch in the feed power supply.The isolator switch must be easily accessible on a wall close to the machine.In the emergency, the user should turn off the power supply and close shutoff valves in the water and (where present) steam supply lines.In case of the increasing temperature after all water is evaporated from the steam generator, the device would shut off the power supply at the steam generator.The review of incidents related to amigo flushers did not reveal any other similar complaint, hence the reported incident is a single occurrence.Based on the collected information, the claimed malfunction is considered a random component failure and the exact cause of the contactor failure is unknown.In summary, according to the gathered information the involved amigo washer was used when the incident occurred.Based on the performed evaluation of the device, the electrical contactor was faulty, hence the device was not according to its specification.No injury or other health consequences were reported to be a result of this event.This complaint was decided to be reported the competent authorities in abundance of caution due to customer allegation that the involved user almost burned their hands.
 
Manufacturer Narrative
The process of information collection and analysis is till on-going.The investigation is to be compiled and its final conclusion will be provided in the next report.
 
Manufacturer Narrative
The information collection and analysis for purpose of investigation is still on-going.Additional information will be provided in the next report.
 
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Brand Name
AMIGO
Type of Device
WASHER OF BODY WASTE RECEPTACLES
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. piotra wawrzyniaka 2
komorniki PL-62 052
PL  PL-62052
MDR Report Key12134960
MDR Text Key261230235
Report Number3007420694-2021-00099
Device Sequence Number1
Product Code FLH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberSXXO301ACON6025
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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