MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. TORNADO; WASHER OF BODY WASTE RECEPTACLES

Model Number FA3U129130HAT1

Device Problem Electrical Shorting (2926)

Patient Problem Electric Shock (2554)

Event Date 07/28/2022

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: 9616031, 3004147784, 3012068831.Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.Inspection of the tornado flusher did not reveal any defect.The flusher was tested for electrical safety and passed the test.It was indicated that during the arjo engineer's work with the device, the flusher was plugged in to the power supply and it was also turned on.The arjo engineer removed the lid from the top of the device to have an access to the electrical parts.Then the arjo engineer interrupted the flusher's work throughout opening the door.This caused that the steam went out from the flusher on to the electrical parts and the flusher¿s metal surface.As a result, the metal surface and some electrical parts might have become wet.Therefore, a voltage could appear on the metal surface.When the arjo engineer touched this part (the metal surface inside of the flusher) he felt an electric shock.The tornado flusher service manual contains the following information and warnings: "warning! the machine is connected to the electricity supply and some components are live." in summary, the complaint was assessed as reportable due to an electric shock sustained by the arjo engineer while maintaining the device.The device did not fail to meet its specification since no malfunction was found in the involved tornado flusher.The event was a result of an engineer lack of caution.The device was not used by a patient or a caregiver when the event occurred.

Event Description

Arjo was notified of an event involving a tornado flusher.It was reported to arjo that arjo engineer suffered an electric shock during maintenance of the tornado device.There was no medical intervention required and no visible marks on the skin.

• Brand Name: TORNADO
• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15292635
• MDR Text Key: 305507206
• Report Number: 3007420694-2022-00137
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FA3U129130HAT1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• 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