MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O. SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AP32811EU1010

Device Problem Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was evaluated by the arjo qualified representative.According to the results of inspection, no electrical malfunction was detected.The investigation is on-going and additional information will be provided within the next report.

Event Description

Arjo was notified by the customer facility that there were electrical breakdowns to the casing of the bathtub.It was reported that the nurse felt like she received an electric shock, when she touched a part of the bathtub.

Manufacturer Narrative

Arjo was notified by the customer facility that there were electrical breakdowns to the casing of the system 2000 bathtub, because the nurse felt like she received an electric shock, when she touched a part of the bathtub (unknown what part).There was no injury or other health consequence reported.Therefore the occurred event is considered as mild electrical shock.The device was evaluated by the arjo qualified representative.According to the results of inspection, no electrical malfunction (such as breakdowns) was detected.Moreover, in april 2019 electrical measurements of the bathtub, electrical installation and socket to which bathtub was connected, were performed by the 3rd party for the customer facility, but did not reveal any anomaly or malfunction.Please note that the bathtub was connected to the power supply with a ground fault circuit interrupter (gfci).System 2000 is intended for therapeutic bathing and showering hospital or care facility residents under the supervision of trained skilled nursing staff in accordance with the instructions outlined in the instructions for use (ifu).Please note that system 2000 instructions for use (ifu; 04.Ar.12_11) delivered with this device provides list of requirements regarding electrical installation supplying power to the bathtub: "to avoid electric shock, make sure that the equipment is connected to: - continuously powered supply mains with protective earth.- separate fuse and ground fault circuit interrupter (gfci) - a mains disconnection device - equipotential bonding point all installations must be in accordance with local codes and regulations." the bathtub was connected to the power supply with gfci, so it was in line with the manufacturer requirements.Gfci is a type of circuit breaker which shuts off electric power when it senses an imbalance between the outgoing and incoming current.The main purpose is to protect people from an electric shock caused when some of the current travels through a person's body due to an electrical fault such as a short circuit, insulation failure, or equipment malfunction.The gfci breaks the circuit when it detects an imbalance.The customer facility did not reported that such situation (power shut off) occurred.Each system 2000 bathtub is equipped with a ground cable during assembling at the manufacturing facility.Moreover, before release of the product, it must be checked on electrical safety tests.The results are recorded in the device history record (dhr).Dhr for the involved system 2000 unit was reviewed, but no anomaly was found.According to this document the device passed all performed electrical tests.Please note that system 2000 was designed and verified to be in accordance with iec 60601-1 and provides electrical protection against electrical shock of "b" degree.Ifu also includes the requirement to check electrical installation (to be performed by authorized electrician) in intervals according to local requirements.According to the information provided by customer facility this is performed on an annual basis.Based on the provided results of electrical measurements conducted in april 2019, there was no malfunction confirmed neither within the device nor electrical supply installation.Based on the collected information and performed analysis it could not be confirmed that electrical shock due to contact with and flow of electrical current occurred.Looking at the event scenario and fact that no health consequence for the involved nurse were reported, it is considered very likely that this mild electrical shock was caused by an electrostatic discharge (esd) or impulse.Esd is the sudden flow of electricity between two electrically charged objects caused by contact, an electrical short, or dielectric.It can cause pain, but is not life threatening.However, as it is not possible to confirm this supposition with absolute certainty, the root cause of this event is impossible to define.In summary, according to the customer allegation, nurse received an electric shock due to contact with the bathtub, so the device did not perform as intended.It was not specified if the device was used for the patient hygiene when this event occurred.This complaint was decided to be reported to the competent authorities out of an abundance of caution due to allegation that nurse received an electric shock.

Manufacturer Narrative

Please note that collection of information in order to complete the investigation regarding this event is still ongoing and the final conclusions are not yet available.Additional information will be provided within the next report.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O.; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 8491069
• MDR Text Key: 141210069
• Report Number: 3007420694-2019-00061
• Device Sequence Number: 1
• Product Code: ILJ
• UDI-Device Identifier: 05055982717618
• UDI-Public: (01)05055982717618(11)171120
• 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: 06/06/2019

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: AP32811EU1010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2019
• Distributor Facility Aware Date: 03/13/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 03/13/2019; 03/13/2019
• Supplement Dates FDA Received: 05/07/2019; 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other