MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB CENTURY

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for century, we have found a very low number of other similar cases where the pt fell out of the device.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 rep at the customer site and found to be out of the specification.The device was being used for pt handling and in that way contributed to the event.From the info rec'd, it is unk what kind of injury occurred to the pt as a result of this incident.However, it has been decided to report this event because of fall and reported injury to the head.The rec'd info and our eval as described above are showing that if the century's warnings and procedures and preventive maintenance schedule were followed in accordance to instruction for use, there would be no pt or caregiver at risk.We have not been able to find any contributing mfg 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 ; 2103170412
• MDR Report Key: 3737950
• MDR Text Key: 21802868
• Report Number: 9611530-2014-00019
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1