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

Model Number AR52311US0111

Device Problems Device Tipped Over (2589); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

The cause of the tip over of the unit appeared to be that the left rear bolt holding the leg in place pulled out.Bath's bolts were checked and this bolt appeared to be defective - passable due to damaged thread.Also due the tub tipping over the tub shell was cracked as it hit the floor.The investigation is on-going and further information will be provided in the next report.

Event Description

Arjo was informed about an event with involvement of system 2000 bath.It was reported that the device was being tested by the arjo technician and when he leaned on the tub, the tub proceeded to tip over and dumped out the water over the floor.No injury was reported to be a result of this event.

Manufacturer Narrative

The investigation to identify a cause of the reported malfunction is still on-going.Further information will be provided in the next report.

Manufacturer Narrative

Arjo was informed about an event with involvement of system 2000 bath.It was reported that the device was being tested by the arjo technician and when he leaned on the tub, the tub tipped over and dumped out the water over the floor.No injury was reported to be a result of this event.The cause of the bath tipping over appeared to be related to the left rear bolt (which holds the leg in place) being pulled out.Bath's leg bolts were checked and this bolt was passable due to damaged thread.Also due the tub tipping over the tub shell became cracked as it hit the floor.The device was removed from use.The described fault occurred during installation which was performed according to the assembly and installation manual, which states the following in section related to bath¿s legs: ¿(¿) ensure that the bushings are positioned correctly against the panel.Tighten the screws to a torque of 44nm.¿.No defect was noticed before installation of the screw in bath leg.Bolts were checked with torque wrench as instructed.The arjo technician found faulty bolt possible to be pulled out.To verify a possibility of part manufacturing error the current manufacturing stock check was performed, but no non-conformities were detected.The evaluation of the device and damaged component did not lead to any clear conclusion.Based on the conducted investigation it was not possible to determine the exact cause of the screw fault and the event occurrence.Please note that if any further information affecting the conclusion of the investigation will be provided after its closure, it will be updated accordingly.In summary, the system 2000 bath was not used, when the event occurred, but was tested by the qualified personnel.Based on the performed evaluation of the arjo device, it was not according to the manufacturer¿s specification as the leg screw¿s thread was damaged.This complaint was decided to be reported to the competent authorities in abundance of caution due to a risk of an injury occurrence related to bath tipping over.

Manufacturer Narrative

The information collection for purpose of the investigation to identify a cause of the reported malfunction is still on-going.Further information will be provided in the next report.

• 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
• MDR Report Key: 10475563
• MDR Text Key: 207183854
• Report Number: 3007420694-2020-00148
• Device Sequence Number: 1
• Product Code: ILJ
• UDI-Device Identifier: 05055982736343
• UDI-Public: (01)05055982736343(11)200323
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AR52311US0111
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other