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

Model Number AP31212US1011

Device Problems Fracture (1260); Device Tipped Over (2589)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

The involved device was evaluated by the arjo representative.According to the results the broken bolt had damaged threads.The investigation is ongoing and further information will be provided in the next report.

Event Description

Arjo was informed about the event with involvement of the system 2000 bath.It was reported that the tub tipped about 25-30 degrees to the side when the leg bolt broke and the bath leg loosened.No patient was involved and no injury was reported.

Manufacturer Narrative

Arjo was informed about an event with involvement of the system 2000 bath.It was reported that the tub tipped about 25-30 degrees to the side when the leg screw broke and the bath leg loosened.No patient was involved and no injury was reported.The involved device was evaluated by an arjo representative.Based on the results of the evaluation, the bath tipped over due to broken leg bolt, which caused lack of connection between bath frame and leg and resulted in instability of the device.The bolt in question broke into two pieces - first piece detached with the leg and second piece of the broken bolt remained in the tub frame.The second piece of the bolt needed to be damage to enable its removal from the bathtub and installation of the new part.Inspection of the broken bolt showed that the part had damaged threads.Each system 2000 bath is equipped with two legs fastened to the bath frame with 4 screws (2 pieces for each leg).Both screws of the bath¿s leg were removed and they were replaced with new parts.Second bolt of the affected leg was replaced preventively.The involved system 2000 bath was installed by arjo technician on october 2019 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.¿ at the time of the installation, no screw defect was noticed.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.Based on the performed evaluation of the arjo device, it was not according to the manufacturer¿s specification as the leg screw was broken.This complaint was decided to be reported to the regulatory authorities in abundance of caution due to risk of an injury occurrence related to bath tipping over.

Manufacturer Narrative

The involved device was evaluated by the arjo representative.According to the results the broken bolt had damaged threads.Both pieces of bolt were removed from the bath and it was replaced with a new part.The investigation is still ongoing and further information will be provided in the next report.

Manufacturer Narrative

Analysis of the collected information to provide a final conclusion of the investigation is still ongoing.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: 10406355
• MDR Text Key: 202943267
• Report Number: 3007420694-2020-00139
• 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,Followup,Followup
• Report Date: 11/06/2020

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: No Information
• Device Model Number: AP31212US1011
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 07/21/2020; 07/21/2020
• Supplement Dates FDA Received: 09/11/2020; 10/09/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other