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

Model Number AR33312US0011

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).The involved bath was evaluated by the arjo qualified representative.According to the inspection results, one of the bolts connecting tub shell with bath panel was out and the tub shell was cracked in one spot.The investigation is on-going and further information will be provided in the next report.

Event Description

Arjo was notified about an event with involvement of system 2000 bath.It was reported that during use the tub shell came loose on one side (did not detach from the bath panel) and cracked.The resident was on the lift when it happened.No injury was reported.

Manufacturer Narrative

Arjo was notified about a complaint with involvement of system 2000 bath and arjo alenti bathing lift.It was reported that during use, the tub shell came loose on one side (did not detach from the bath panel) and cracked in one point.The resident was all the time supported by the bathing lift when the bath's tub malfunction occurred.No injury was reported to be a result of the bathtub malfunction.The involved bath was evaluated by the arjo qualified representative.According to the inspection results, one of the bolts connecting tub shell with bath panel was out and the tub shell was cracked in one spot.The bath in question was not under the arjo service agreement, so it was not possible to confirm that regular maintenance services were carried out for this bathtub.It was reported by customer facility that the right screw (looking at the front of bath panel) holding the bathtub shell loosened, which led to the crack of the laminate.Based on the collected information the involved device was not under the arjo service agreement, but was serviced internally by the customer.According to the instructions for use (ifu; 04.Ar.12_1gb issued in (b)(6) 2010) 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.The system 2000 is subject to wear and tear.Therefore, 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 section "care and preventive maintenance" of ifu includes warnings and other information reminding of the preventive maintenance requirements e.G.: "system 2000 has to be serviced according to the preventive maintenance schedule (qualified personnel action/check)." "continuing to use this product without conducting regular inspections or continuing to use this product when a fault is found will seriously compromise the user and residents safety [.] preventive maintenance specified in this manual can prevent accidents." "the following actions must be carried out by qualified personnel, using correct tools and knowledge of procedures.Failure to meet these requirements could result in personal injuries and/or unsafe product.The system 2000 bath must be serviced once a year in accordance with the maintenance and repair manual.Please note that 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 revealed one similar incident.There was no confirmation that the customer facility performed yearly preventive maintenance service and routine checks according to the manufacturer's requirements.Therefore, based on the collected information the most probable cause of the reported malfunction is related to not following the maintenance requirements or lack of preventive maintenance.In summary, according to the customer allegation, one side of the tub's shell has loosened from the bath 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 in abundance of caution due to information that tub shell started to detach 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
• MDR Report Key: 8666427
• MDR Text Key: 147323784
• Report Number: 3007420694-2019-00091
• 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: 07/04/2019

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: AR33312US0011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/04/2019
• Distributor Facility Aware Date: 05/09/2019
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/04/2019
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other