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

Model Number AR31801US1010

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 02/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The defective bath was removed from usage and evaluated by the qualified (b)(4)representative.According to the results, the washer of the left screw holding the tub shell was damaged, which led to detachment of the tub shell's left side.The tub shell was also cracked on the right side due to the weight of water and lack of proper support on the left side.The shell did not fully detach and did not fall to the floor.The involved device was not under the (b)(4) service agreement, but was serviced internally by the customer.The investigation is ongoing and further information will be provided within the next report.

Event Description

(b)(4) was notified about an event with involvement of system 2000 bath.It was reported that the caregiver was in the process of moving the patient with the ceiling lift (prior to moving the patient to the bath), when the tub shell came loose on the left side.The tub shell also cracked on the right side, which caused water to spill to the floor.The caregiver pulled back the patient, who was still in the lift's sling moving in position for bath.The patient was not injured.The caregiver reported a back pain and anxiety and consulted a doctor.

Manufacturer Narrative

Arjo was notified about an event with involvement of system 2000 bath.It was reported that the caregiver was in the process of moving the patient with the ceiling lift (prior to moving the patient to the bath), when the tub shell came loose on the left side.The tub shell also cracked on the right side, which caused water to spill to the floor.The caregiver pulled back the patient, who was still safely secured in the lift's sling and stopped further downward movement into bath.The patient was not injured.The caregiver reported a back pain and anxiety and consulted a doctor.No further information regarding injury was available.The involved bath was removed from usage and evaluated by the qualified arjo representative.According to the results, the washer of the left screw holding the tub shell was damaged, which led to loosening of the screw and detachment of the tub shell's left side from the bath panel.The tub shell was also cracked on the right side due to the weight of water and lack of proper support on the left side.Structure of the bathtub was intact.The involved device was not under the arjo service agreement, but was serviced internally by the customer.Last maintenance performed by arjo took place in april 2016 upon installation of the bathtub in the customer facility.According to the instructions for use ((b)(4) issued in january 2015) delivered with the involved device, the customer should perform a bath's check before every use for any damage and remove the device from use if any malfunction is found.Ifu informs that to avoid malfunction resulting in injury, the customer should make sure to conduct regular inspections and follow the recommended maintenance schedule including yearly checks performed by qualified personnel.The ifu includes warnings and other information reminding of the preventive maintenance requirements e.G.: "to avoid injury and/or unsafe product, the maintenance activities must be carried out at the correct frequency by qualified personnel using correct tools, parts and knowledge of procedures.Qualified personnel must have documented training in maintenance of this device." the system 2000 bath must be serviced once a year in accordance with the maintenance and repair manual.Please note that current maintenance and repair manual for system 2000 (09.Ar.07_7) in section "locking, lubrication and torque" provides requirement to check the screws in question during the annual maintenance and to tighten them if necessary.There was no confirmation that the customer facility performed yearly preventive maintenance service and routine checks according to the manufacturer's requirements.The review of reportable events with the involvement of the system 2000 bath in last 5 years did not reveal any similar incident.In summary, according to the customer allegation, the one side of the tub's shell has detached from the panel and the laminate cracked, so the device did not perform as intended.The bathtub was used for patient hygiene and in that way it played a role in this event.This complaint was decided to be reported to the competent authorities due to information that tub shell started to detach during use and the caregiver sustained an injury.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O.; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 8377087
• MDR Text Key: 141220709
• Report Number: 3007420694-2019-00034
• 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: 03/15/2019

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: AR31801US1010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2019
• Distributor Facility Aware Date: 02/18/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2019
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 02/18/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other