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

Model Number AR33212-US

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number 9611530.Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.The involved device was evaluated by the arjo representative.According to the results of inspection, one of the leg screws was broken.All four leg screws on both tub legs were replaced.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 the tub tilted to one side after being filled and patient placed.No injury occurrence was reported.

Manufacturer Narrative

The information collection and analysis for purpose of investigation is still on-going.Further information will be provided in the next report.

Manufacturer Narrative

Arjo was notified about an event with involvement of system 2000 bath.It was reported that the tub tilted to one side after being filled and patient was to be placed.No injury occurrence was reported.The involved device was removed from use and evaluated by the arjo representative.According to the results of inspection, one of the leg screws was broken.All four leg screws on both tub legs were replaced.The device was not under the arjo service contract.Each system 2000 bath is equipped with two legs fastened to the bath frame with 4 screws (2 pieces for each leg).Based on the results of evaluation performed after the event, the bath tipped over due to broken leg screw, which caused lack of connection between bath frame and leg and resulted in instability of the device.Please note that service of the system 2000 bath should be performed following the preventive maintenance schedule.It provides instructions regarding the leg screw and that how its condition and function should be verified: ¿screws holding legs shall be checked for torque every year.¿ ¿torque 44 nm.Check every year.¿ the above maintenance requirements should be followed to avoid loosening of the screw and possibility of breakage upon prolonged use in this state.The claimed bathtub was manufactured over 17 years before this event was reported.The normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instructions.Therefore, this product expected operational life has been exceeded by about 7 years.In summary, the system 2000 bath was used, when the event occurred and therefore was involved in the incident.Based on the performed evaluation of the arjo device, it was not functioning according to the manufacturer¿s specification as the leg screw broke.This complaint was decided to be reported to the competent authorities in abundance of caution due to risk of an injury occurrence related 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
• MDR Report Key: 11472205
• MDR Text Key: 240677895
• Report Number: 3007420694-2021-00037
• 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
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AR33212-US
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other