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 Type  malfunction  

Event Description

Ref imp report number: (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for system 2000 we have found a low number of other similar cases - uncommanded down movement of the bath.We have been able to establish that there is no complaint trend concerning these kind of events.Please note that arjohuntleigh manufactured over (b)(4) baths to date.The device was inspected by an arjohuntleigh rep at the customer site and found to be to the spec.The device was being used for pt handling and in that way contributed to the event.From the info received caregiver crushed muscle to left foot little toe area.X-ray proved no broken bones.We have not been able to find any contributing mfg anomalies.From above findings we conclude that this incident was caused by user error - user not correctly trained.The caregiver did not follow warnings included in ifu - tub was lowered onto obstruction - lift's actuator.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 3959902
• MDR Text Key: 22002080
• Report Number: 9611530-2014-00051
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Remedial Action: Notification
• Type of Report: Initial

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?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AR32201-GB
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1