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

Model Number AR31801EU1000

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device inspection performed by an arjo technician revealed that the print circuit board (pcb) failed.When he opened the box behind the panel, there was water inside.He could not determine exactly where the water had gotten inside, as there were no cracks on the panel or the cover of the box.The control panel and pcb were replaced.The investigation is ongoing and further information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified about an event with involvement of system 2000 bath.It was reported that while the patient was sitting inside the bath, the bath started to raise unintended, when the caregiver pressed the shower handle button.Two seconds after that, the bath stopped.No injuries to the patient were reported.

Manufacturer Narrative

The device inspection performed by an arjo technician confirmed malfunction of the print circuit board (pcb).When the arjo technician opened the box behind the panel, there was water inside.The arjo technician could not determine exactly where the water had gotten inside, as there were no cracks on the panel or the box cover.Based on the information gathered, it seems likely that the water got under the panel overlay and came into contact with the electronics inside the assembly.The contact between the water and the electronics could have led to a short circuit, resulting in uncommanded movement.However, this hypothesis cannot be confirmed with certainty.In summary, the bath was used for a patient hygiene and in that way it played a role in this event.The bathtub was moving upward uncommended due to the device malfunction, so the device was not up to the manufacturer¿s specification.The complaint was decided to be reported due to uncommanded bath movement upwards while the patient was in the bath, which could have caused a device destabilization and patient's fall or entrapment.

Event Description

Arjo was notified about an event with involvement of system 2000 bath.It was reported that while a patient was sitting inside the bath, the bath started to raise unintended.The customer emphasized that the caregivers did not choose the lifting function.Two seconds after, the bath stopped.No patient injury was reported.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18146688
• MDR Text Key: 328247369
• Report Number: 3007420694-2023-00275
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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: AR31801EU1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other