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

Model Number AR32212US1111

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

The involved device was evaluated by the arjo representative.According to the results of inspection, the malfunction of button was confirmed, the faulty panel was replaced, and the device returned to service.The investigation is on-going, and further information will be provided in the next report.

Event Description

Arjo was notified about an event with involvement of system 2000 bath.It was reported that while the patient was sitting on the bathing lift and inside the bath, the bath started raising un-commanded due to faulty button on the control panel.The caregivers used emergency shut off to stop the movement and emergency, lowering to remove the patient from the bath.No patient injury was reported.

Manufacturer Narrative

Arjo was informed about an incident involving system 2000 bath.It was reported by the customer that while the patient was sitting on the bathing lift and inside the bath, the bath started raising uncommended due to faulty button on the control panel.The caregivers used emergency shut off button which was on the wall to stop the movement and emergency lowering to remove the patient from the bath.Following further communication, the caregiver managed to prevent a collision with the bathing lift that was placed in the bathtub.No patient injury was reported.Arjo service technician visited the customer facility to perform a device inspection.The malfunction of button was confirmed.There was no visible sign of the button damage.According to arjo representative, it seemed that the button could be pressed as intended, but after pressing the button few times it got stuck on the control panel causing the ¿up¿ function to remain active.It was not possible to determine what was the cause of the reported button malfunction.The faulty panel was replaced.Before the bath was released for further use, it was tested and confirmed as operated correctly.In summary, the bathtub was used for a patient hygiene and in that way it played a role in this incident.The bathtub was moving upward uncommended due to faulty button on the control panel so the device was not up to the manufacturer¿s specification.The complaint was decided to be reported in abundance of caution, due to the possible scenario of event: malfunction of the bath caused an uncommended movement upwards and the patient was on the bathing lift, which could have caused a device destabilization and patient's fall or entrapment.

• Brand Name: SYSTEM 2000
• 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: 10690227
• MDR Text Key: 211698089
• Report Number: 3007420694-2020-00162
• 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: 11/13/2020

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: AR32212US1111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other