MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN; BATH, HYDRO-MASSAGE

Model Number AZL33216-GB

Device Problem Unintended Electrical Shock (4018)

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

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The collected information is under further review.Additional information will be provided within the next report.

Event Description

It was reported that nurse received an electric shock from the lift arm, when trying to move it manually.No patient was involved.There is no indication of any injury or medical treatment.The device was taken out of use and inspected by arjo representative.The fault could have not been replicated.The bath was tested for an electrical safety on all metal parts and it passed all tests.It was suspected that this was a static electric shock.

Manufacturer Narrative

Arjo was notified about an event with involvement of the malibu/sovereign bathtub.It was reported that nurse received an electric shock from the lift arm (for the bath's own chair), when trying to move it manually.No patient was involved.There is no indication of any injury or applied medical treatment.The device was taken out of use and inspected by arjo qualified personnel, but the fault could have not been replicated.The bath was tested for an electrical safety on all metal parts and it passed all tests.No further action was necessary.According to the inspection results, which did not reveal any electrical malfunction, it was suspected that the reported event was a static electric shock.The review of reportable events with the involvement of the malibu/sovereign bathtub in last years revealed low number of similar incident.Based on device's evaluation (including electrical test) there was no malfunction that could have caused or contributed to the alleged incident.It was also not possible to replicate the failure reported to arjo.Therefore it is suspected that when the nurse touched the metal lifting arm, he experienced a shock caused by the electrostatic discharge.Please note that design of the malibu/sovereign isolation system between applied parts and electrical parts was tested for the requirements of the safety standard iec 60601-1 and was confirmed to be compliant.The claimed bath is equipped with the type b applied part protection against electrical shock in accordance with iec 60601.It should be also underlined that maintenance and repair manual for this bathtub (09.Az.01/0gb dated on may 2008) includes requirements to check all electrical cabling and the earth wiring connections.In summary, based on the reported information the nurse sustained an electric shock, when touched the bathtub's lifting arm.The bathtub was not used for patient hygiene at the time of event.According to the device's evaluation results it met the manufacturer's specification.This complaint was decided to be reported to the competent authorities based on the customer allegation that the electric shock occurred.

• Brand Name: MALIBU/SOVEREIGN
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 7951287
• MDR Text Key: 123690536
• Report Number: 3007420694-2018-00196
• Device Sequence Number: 1
• Product Code: ILJ
• 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: 10/31/2018

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: AZL33216-GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2018
• Distributor Facility Aware Date: 09/24/2018
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2018
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other