MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MALIBU; ILJ

Model Number AZL23110-GB

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Electric Shock (2554)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended.Additional information will be provided following the conclusion of the investigation.

Event Description

Initially it was reported to arjohuntleigh representative that: "after filling the bath, the carer received an electric shock while standing in water on the floor and operating the control handset (while hoisting female patient from bath).An ambulance was called and carer was taken to hospital." it was noticed that the caregiver was released after approx.1 hour.Her injury was described as follows: "injury to finger, raised colour, no further treatment (described as pink' area on fingertip) ".

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events for malibu we have found one other similar case where electrical shock occurred.We have been able to establish that there is no complaint trend concerning these kinds of events.The device was being used for the patient handling - hoisting patient from the bath, and in that way contributed to the event.It was reported by the customer that caregiver felt a pain in her shoulder after pressing a button on the handset and the lights in the bathroom went out.There is no information what kind of malfunction caused the event during use with a patient, however further examination by arjohuntleigh's representative revealed no faults within a device - function test showed that the device was working to its specification.No broken isolation was found either.The device has been exanimate by a technician- all bath functions were found to be working correctly.Also the technician performed a visual inspection of the wires, handset and control panel technician could not find any signs of electric shock such as burn marks, damage or blown fuses.Additional information provided to the complaint indicates that: no reason identified as to why the bathroom lights went out' , as bath and lights are not situated on the same electrical circuit.Moreover, the manager of the facility is not sure what "actually" happened.All baths are equipped with instruction for use which clearly inform how to safety and properly use the bath.Instruction for use for malibu contains warnings: "electrical hazard.Do not use electrical devices in or near the bath.It can cause bodily injury to both the resident and the caregiver." "the unit must be continuously powered and connected to a mains disconnection device and to separate fuse with ground fault interrupter in accordance with local codes and regulations by certified electrician." also ifu contains preventive maintenance where is information that caregiver should: check electrical installation (to be performed by authorized electrician) intervals according to local requirements.After reviewing the complaint it comes forward that the device was according to specification when the event occurred.The device was in good working condition, technicians could not recreate the event, all bath function work in correct way.There is unclear what exactly happened in the facility.No factual indication was found that the device caused or contributed to the event.

• Brand Name: MALIBU
• Type of Device: ILJ
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio,, TX 78247 ; 2103170412
• MDR Report Key: 5554112
• MDR Text Key: 42150273
• Report Number: 3007420694-2016-00044
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/20/2016,03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: AZL23110-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2016
• Distributor Facility Aware Date: 03/21/2016
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/07/2016
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other