MAUDE Adverse Event Report: GETINGE DISINFECTION AB TYPHOON; WASHER OF BODY WASTE RECEPTACLES

Model Number SP6000AR010

Device Problem Electrical Shorting (2926)

Patient Problem Electric Shock (2554)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported to arjo that arjo technician suffered an electric shock in the arm during maintenance of the typhoon device.The arm was touching both the typhoon metallic cover and the neutral of solenoid valve.

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 inspection of the involved device revealed that the ground cable was powered by another machine even though disconnected.Once the ground cable was disconnected, it worked as intended.Analysis of collected information is ongoing to provide the final conclusions.

Manufacturer Narrative

The information collection and analysis for purpose of the investigation is on-going.Additional information will be provided in the next report.

Manufacturer Narrative

Arjo received a customer complaint where it was indicated that arjo service technician suffered a minor electric shock in the arm during maintenance of the typhoon device at customer facility.The technician was touching at the same time, both the typhoon metallic cover and the neutral of solenoid valve.Following the information collected, the metallic cover of the typhoon flusher was under voltage and when rubbing slightly it was possible to feel tingling.Arjo technician measured the metal cover of the flusher and the ground using the universal controller with result of 10v alternating.According to the collected information, the typhoon flusher inspection revealed no malfunction.The arjo technician made tests with the flusher and it worked properly.Based on the information received from arjo technician, the facility has its earthing system working on a it network.The it power network could have an electrical fault.When an arjo technician touched the metal cover and the neutral solenoid valve (l (phase)-pe-n), a short circuit loop was formed.The facility¿s ground cable connected to the flusher was measured by arjo technician and the result was 230v (the measurement was taken between protective earth (pe) and neutral (n)).This result suggests that in the it network at least one fault was present.In case the short circuit occurs in the it network, the device metallic covers might be connected with the power wire (neutral or phase wire).Only when neutral and phase wire are connected the electric shock might occur.This situation is unlikely during regular usage of the device, since the device¿s components are in an enclosure cover.In the reported event, the technician failed to unplug the device from the electrical network, while servicing the internal parts of the device.The service manual for flushers provides the following information and warning: warning: "the machine is connected to the electricity supply and some components are live." the technician suggested to the customer to check their electrical network.To sum up, the complaint was assessed as reportable due to minor electric shock sustained by arjo technician during device maintenance.The device was not used by the patient or caregiver.The product failed its performance specification from use error, since a technician created a short circuit loop by touching the metal cover and the neutral solenoid valve while the device was connected to the electrical network.

• Brand Name: TYPHOON
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11, vaxjo kronobergs lan [se-07]; vaxjo 35115 ; SW 35115
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11, vaxjo kronobergs lan [se-07]; vaxjo 35115 ; SW 35115
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13061277
• MDR Text Key: 282781763
• Report Number: 3007420694-2021-00175
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SP6000AR010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2007
• 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
• Patient Sex: Male