MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR32201-GB

Device Problems Device Tipped Over (2589); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 06/16/2014

Event Type  Injury  

Event Description

It was initially reported by company representative that carers were preparing to remove client from the bath and lowered tub on to the actuator of mobile hoists, which caused bath feet to raise from floor.When hoist freed itself, bath foot plate caught carers little toe.From the info received caregiver crushed muscle to left foot little toe area.X-ray proved no broken bones.Mfr ref number 9611530-2014-00051.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• MDR Report Key: 3959909
• MDR Text Key: 21241391
• Report Number: 1419652-2014-00185
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2014,06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AR32201-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2014
• Distributor Facility Aware Date: 06/24/2014
• Device Age: 7 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other