MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MALIBU/SOVEREIGN (INCL. DIGNITY); BATH, HYDRO-MASSAGE

Model Number AZR23110-GB

Device Problem Unintended Electrical Shock (4018)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

The device has been evaluated by the arjo representative.According to the results, the bath is in good condition, without any visible damage and was working within manufacturer specification.The investigation is on-going and additional information will be provided in the next report.

Event Description

Arjo was notified about an event with involvement of malibu bath.It was reported that a caregiver was raising the bath chair using the handset with a tub full of water.At this moment, the handset cable touched the caregivers left thigh and the caregiver reported getting an electric shock feeling.This pain was felt for about 30 minutes after the event.

Manufacturer Narrative

Arjo was notified about an event with involvement of malibu bath.It was reported that a caregiver was raising the bath chair using the handset with a tub full of water.At this moment, the handset cable touched the caregivers left thigh and the caregiver reported getting an electric shock feeling.This pain was felt for about 30 minutes after the event.The involved device has been evaluated by the arjo representative, including check of the earth wiring connections and the hand control.According to the results, the bath was in good condition, without any visible damage and it was working as per the manufacturer¿s specification.According to the performed analysis, the nurse could have experienced a shock caused by the electrostatic discharge as it occurred upon contact with insulated handset¿s wire.Electrostatic discharge is the sudden flow of electricity between two electrically charged objects caused by contact, an electrical short, or dielectric breakdown.Please note that design of the malibu/sovereign isolation system between applied parts and electrical parts of was tested for compliance with requirements of the safety standard iec 60601-1.The claimed bath is equipped with the type b applied part protection against electrical shock in accordance with iec 60601-1.Please note that the preventive maintenance schedule for this product includes requirements to check all electrical cabling and the earth wiring connections at least every year.Following the performed investigation it was not possible to confirm occurrence of malfunction which could have led to the electric shock.Therefore taking in to account the customer allegation it was not possible to recreate the event and to determine its exact root cause.In summary, based on the reported information the nurse sustained an electric shock during use of the device.It is unknown if the bathtub was used for patient hygiene at the time of event.According to the device¿s evaluation results, no malfunction was detected and the bath was up to the manufacturer¿s specification, but it was operated by the caregiver when the incident occurred and in that way it played a role in the event.This complaint was decided to be reported to the competent authorities in abundance of caution due to alleged electrical shock sustained during use of the arjo bath.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 11228923
• MDR Text Key: 240669222
• Report Number: 3007420694-2021-00009
• Device Sequence Number: 1
• Product Code: ILJ
• UDI-Device Identifier: 05055982701440
• UDI-Public: (01)05055982701440(21)VEPL00016254
• 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
• Report Date: 02/22/2021

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: Other
• Device Model Number: AZR23110-GB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other