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

Model Number AP33212-CA

Device Problem Device Tipped Over (2589)

Patient Problem Pain (1994)

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjo was notified of an event involving a system 2000 bathtub.The bathtub was being filled.Caregivers were attaching a resident to a ceiling lift that was above the tub.The caregiver heard a creak, after which the system 2000 bathtub shell tilted onto the caregiver's hip and back.The caregiver remained at work for about two more hours, after which went to hospital for examination.The caregiver experienced general soreness throughout the body, but there were no bruises or broken bones.When the device was inspected, the screw of the back leg on the right side of the tub was found to be sheared off.

Manufacturer Narrative

Arjo was notified of an event involving a system 2000 bathtub.The bathtub was being filled.Caregivers were attaching a resident to a ceiling lift that was above the tub.The caregiver heard a creak, after which the system 2000 bathtub shell tilted onto the caregiver's hip and back.The caregiver remained at work for about two more hours, after which went to hospital for examination.The caregiver experienced general soreness throughout the body, but there were no bruises or broken bones.The device was inspected by an arjo service technician.It was found that the screw of the back leg on the right side of the tub was snapped.Based on the device inspection results, the post-market surveillance data and consultation with the arjo technical department, we came to the conclusion that the issue reported seems to be related to normal wear of the component.The system 2000 bath involved in the event was manufactured about 19 years before this malfunction occurred.The equipment is subject to wear and tear, and recommended maintenance instructions must be performed when specified to ensure that the equipment remains within its original manufacturing specification.Following the instruction for use (ifu) for system 2000 bath (04.Ar.09/1 gb): "the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventive maintenance as specified in the operating and daily maintenance instruction".Due to malfunction reported, the system 2000 bath did not meet the performance specification.The bath was used with the resident when the event occurred.This complaint was decided to be reported due to bath tipping over 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: 18919726
• MDR Text Key: 337843797
• Report Number: 3007420694-2024-00076
• 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
• Report Date: 04/15/2024

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: AP33212-CA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2005
• 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