MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Type  malfunction  

Event Description

Ref imp# (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for system 2000 we have found a number of other similar cases.We have been able to establish that there is no complaint trend concerning these kind of events - uncommanded movements of the bath.Please note that arjohuntleigh manufactured over (b)(4) baths to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be to the specification.The device was being used for pt handling and in that way contributed to the event.No injury to the pt occurred - pt was secured by sling.Toe's injury to the caregiver was reported, however, provided information showed that it is unsure why the caregiver would sustain any injuries.From above findings we conclude that this incident was caused by user error- user not correctly trained.The caregiver didn't follow warnings included in ifu - tub was lowered onto obstruction - lift's actuator.We have not been able to find any contributing manufacturing anomalies.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2421 2; SW 24212
• 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 ; 2102787000
• MDR Report Key: 3764871
• MDR Text Key: 20973777
• Report Number: 9611530-2014-00009
• 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: Health Professional,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: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1