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

Model Number AP01201-GB

Device Problems Unintended Movement (3026); Device Fell (4014)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of evaluation performed by the arjo representative are not available yet.It should be underlined that the involved system 2000 have a gap of 8 centimeters between bath legs and the floor.The update will be provided in the next report.

Event Description

Arjo has been notified about the incident with involvement of system 2000.The customer stated that the bath dropped suddenly on the caregiver¿s foot whilst she was washing bed covers in bath.The bath was half filled with water at this time.Another carer attended and lifted bath off her foot.The customer facility stated that the carer fractured her big toe.The injured carer attended a&e department.According to the information from the customer facility, their in house investigation did not identify any issues with the device.They were not able to establish how this accident could have happened and why the bath would have dropped.

Manufacturer Narrative

Arjo was notified about an incident with involvement of system 2000.The customer stated that the bath dropped suddenly on the caregiver¿s foot whilst she was washing the bed covers in bath.The bath was half filled with water at that time.Another carer attended and lifted bath off her foot.The customer facility stated that the carer fractured her big toe due to that event.The injured carer attended a&e department.According to the information from the customer facility, their in-house investigation did not identify any issues with the device.They were not able to establish how the accident could have happened and why the bath would have dropped.The involved device was taken out of use and evaluated by an arjo representative.No water was in the bath when the technician attended.Visual inspection of the device showed the bath to be in good condition.The scratches on the bathtub¿s surface were found (probably from the other equipment stored in the room).Function test of the bath¿s control panel showed all functions to be working as intended.The bath lifting mechanism was working as intended too.During filling the bath a water leak coming from the drainage was noticed.It was found that the bath had been disconnected from the main waste pipe ¿ possibly due to movement of the bath.It was reconnected and tested to confirm correct operation.When raising the bath up the full height and then lowering a loud bang was heard coming from behind the bath¿s back panel.On further investigation it was found that the rear outer panel was catching on the lower panel screws causing the panel to bow and pop back into position during lowering.These findings were not related to the reported event.According to the photographic documentation taken during visit at the facility, there was the metal frame for a laundry baskets placed near the bath end, which might have been one of the potential obstacles.If during the event bathtub was lowered onto an obstacle, the bath feet could lift up.The caregiver could have placed her foot under the lifted bath foot and whilst cleaning equipment she might lean on the side of the bath, causing the bath to drop on the floor and on the carers toe.Please note that operating and daily maintenance instructions (ifu) of system 2000 (04.Ar.09/1gb dated on (b)(6) 1999) provides guidelines and safety information regarding the device usage, inter alia: ¿when lowering the bath tub the operator must ensure that there are no obstructions in the immediate vicinity that could impede its downward movement.Failure to remove obstructions could result in serious injury to operator/resident and damage the tub.¿ in summary, according to the gathered information the involved system 2000 bath was used, when the event occurred and therefore played role in the event.Based on the performed evaluation of the device, it was functioning according to the manufacturer¿s specification.This complaint was decided to be reported to the relevant regulatory authorities due to indication of a serious injury occurrence.

• 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: 10137628
• MDR Text Key: 195802107
• Report Number: 3007420694-2020-00098
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: AP01201-GB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention