MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AR33312-US

Device Problem Device Tipped Over (2589)

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

Event Date 02/27/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.The follow-up will be sent upon investigation conclusion.

Event Description

Arjo was notified about an event with the system 2000 bath involvement.It was reported that during bathing a patient, the hydraulic line of the bath ruptured resulting in the bathtub falling quickly to the lowest position.After falling to the lowest position, the whole bathtub was tilted forward on the front "duck legs" and the rear legs were in the air.The water poured out on the floor and then the device fell back on the rear legs causing a loud noise.The patient involved did not sustain any injury.

Manufacturer Narrative

Collection of additional information is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

Arjo was notified of an incident involving a system 2000 tub where it was indicated that the bath's hydraulic hose broke while the patient was being bathed.This caused the tub to drop quickly to its lowest position.After lowering, the entire tub tilted forward on its front "duck" legs, and the tub's rear legs were in the air.Water spilled onto the floor and then the bath fell back onto the rear legs, causing a loud noise.The patient involved did not sustain any injury.The bath involved in this event is equipped with a hydraulic pump that supplies oil through a hydraulic hose/line to two pistons located in the support columns.During lowering, the oil returns to the pump by gravity.When the hydraulic hose is loose or broken, the hydraulic system will unseal, resulting in the bathtub dropping rapidly to the bottom, as described in the reported event.It is worth noting that the bath¿s ¿duck¿ legs can be attached to the floor for better stability.An arjo representative visited the customer site to inspect the involved bath.He noticed that the hydraulic hose had been replaced (with not arjo part) by a maintenance technician from the customer facility day after the event.Apart from the hydraulic pump, the system 2000 bath was in good condition (with no visible damages) and it worked properly.Arjo technician, after inspecting the faulty part, determined that the mechanical failure was the cause of the hydraulic hose rapture.This lift was not under arjo service contract and was servicing internally by the customer.During the visit, the arjo representative adjusted the bath legs for drainage purpose.According to additional information received the hydraulic hose that ruptured was the original that came with the bath.The involved device was over 17 years old and was subjected to wear and tear during this time.To ensure that the product remains within its original manufacturing specification, the device¿s owner is obligated to maintain the device according to the instruction for use (ifu): "every week: examine the bath for cracks or other damage.Check for leakage." based on the information received and the analysis performed it can be concluded that normal wear of the hydraulic hose contributed to the event.In summary, the system 2000 tub was being used with a patient and therefore played a role in the event.The device failed to meet its specifications at the time of the event.This complaint was decided to be reported to the competent authorities in abundance of caution due to risk of an injury occurrence related to bath tipping during use.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 13936839
• MDR Text Key: 289776775
• Report Number: 3007420694-2022-00044
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AR33312-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2005
• 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