MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB CENTURY

Device Problems Component Falling (1105); Shelf Life Exceeded (1567); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Injury (2348)

Event Type  malfunction  

Event Description

Reference importer report #(b)(4).

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for century we have found low number of other similar cases where seat detached from lifting unit.We have been able to establish that there is no complaint trend concerning these kind of events.Please note that arjohuntleigh manufactured about (b)(4)century baths to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be out to the specification.The device was being used for pt handling and in that way contributed to the event.Received information showed that complained device wasn't working correctly.It was find difficult to connect seat to the lifting arm.Provided photos confirmed also worn out equipment and damaged seat.From above findings we conclude that this incident was caused by incorrect use of product.Safety of the product wasn't preserved.Product that is not functioning correctly shouldn't be used; also preventive maintenance wasn't performed correctly - transfer latch should be inspected every day.It can be also concluded that this event occurred because of exceeding lifetime of the device.Complained century was in use for about 13 years.If the century's transfer procedures were followed in accordance to instruction for use and preventive maintenance has been correctly performed there will be no pt or caregiver at risk.We have not been able to find any contributing manufacturing anomalies.

• Brand Name: CENTURY
• 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 ; 2102787000
• MDR Report Key: 3723435
• MDR Text Key: 4308774
• Report Number: 9611530-2014-00015
• 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: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2001
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1