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

Model Number AR33212US1010

Device Problems Unintended Movement (3026); No Apparent Adverse Event (3189)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

During the visit at the customer an arjo service technician was notified about two events with involvement of the same system 2000 bath.It was reported that while a patient was sitting on the alenti bath lift placed in the bath, the bath dropped on its own without any user interaction.It was also pointed out that the tub legs were too low and that the tub shell trapped alenti under the tub.There was no injuries sustained as a consequence.The other event was registered under mdr 3007420694-2024-00054.

Manufacturer Narrative

An inspection of the device performed by the arjo technician revealed that the control panel is faulty.The investigation is ongoing and further information will be provided upon conclusion of the investigation.

Manufacturer Narrative

The investigation is ongoing and further information will be provided upon conclusion of the investigation.

Manufacturer Narrative

During the visit at the customer an arjo service technician was notified about two events with involvement of the same system 2000 bath.It was reported that while a patient was sitting on the alenti bath lift placed in the bath, the bath dropped on its own without any user interaction.It was also pointed out that the tub legs were too low and that the tub shell trapped alenti under the tub.There was no injuries sustained as a consequence.The other event was registered under mdr 3007420694-2024-00054 (registered under the record (b)(4)).The device inspection performed by the arjo technician confirmed the control panel failure.It was found that the control panel button got stuck and a short circuit occurred.The bathtub lowering valve turned off and caused the bathtub to lower slowly.There was no water inside the control panel and no mechanical damages were observed.The faulty part was replaced.Based on the information received during the course of the investigation, the exact cause of the failure was not established.In this particular event, the legs of the bath were adjusted to provide sufficient space for the alenti lift legs.The complaint was initially assessed as reportable due to the information indicating the bath dropped.However, after receiving additional information, the bath lowered slowly.No direct risk for a patient was identified.Based on a review of post-market surveillance data, it was determined that the complaint did not meet the reporting criteria.The review showed that the unintended slow lowering of the bathtub during use has not caused or contributed to death or serious injury in the past, and if this type of event were to occur again, it is unlikely to cause or contribute to serious injury or death.Taking all the facts into account, this complaint is deemed not reportable to competent authority.Arjo will not be reporting future complaints of this type.However, arjo will continue monitoring the complaints and report any events in which death and/or serious injury occurred that arjo device contributed to.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 18785912
• MDR Text Key: 336318711
• Report Number: 3007420694-2024-00055
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 04/23/2024

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: AR33212US1010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 01/30/2024; Not provided
• Supplement Dates FDA Received: 03/25/2024; 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2018
• 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