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

Model Number AR33111-US

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number (b)(4).Currently, these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).The involved device was evaluated by the arjo representative.According to the results, tub was in good condition except the snapped leg bolt.The device was removed from service until repaired.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 was filled with water and the resident was set over top of tub in the bathing chair.Tub was being raised up to comfortable working height when it tipped over to the side suddenly.The bath knock the resident over and the resident fell onto the floor along with the bath chair.The resident did not sustain any injuries.After the incident the resident was removed and taken to their room.The facility maintenance found the left leg of tub was sitting crooked.The bathtub was locked out and the personnel straightened leg in order to drain water from tub.

Manufacturer Narrative

Arjo was informed about an event with involvement of a system 2000 bath.It was reported that the bathtub tipped over.At first, the tub was filled with water and the resident was set over top of tub in the bathing chair.Tub was then being raised up to comfortable working height when it tipped over to the side suddenly.The bath knock the resident over and the resident fell onto the floor along with the bath chair.The resident did not sustain any injuries.After the incident the resident was removed and taken to their room.The facility maintenance found the left leg of tub was sitting crooked.The bathtub was locked out and the personnel straightened leg in order to drain water from the tub.The involved device was then evaluated by the arjo representative.According to the results, tub was in good condition except the snapped leg screw (part number: 6131040).The device was removed from service, repaired by replacement of all leg screws and put back to use.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 bolt, which caused lack of connection between bath frame and leg and resulted in instability of the device.According to the information provided, the last preventive maintenance service of this bath was performed on (b)(6) 2020.No issues related to the leg assembly were detected at that time.The assigned technician checked the 4 leg bolts including the one, which later broke and confirmed that the bolts were not loose in the unit.The claimed bathtub was manufactured over 16 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 6 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 regulatory authorities in abundance of caution due to risk of an injury occurrence related to bath tipping over and patient fall.

• 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: 10424902
• MDR Text Key: 203490011
• Report Number: 3007420694-2020-00141
• 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: 09/17/2020

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: Other
• Device Model Number: AR33111-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other