MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN (INCL. DIGNITY)

Device Problems Device Tipped Over (2589); Installation-Related Problem (2965); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Ref # imp (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for malibu/sovereign (b)(4) it was determined there were a low number of other similar cases.We have been available to establish that there is increasing but very low complaint trend concerning these kind of events.(b)(4).With the number of sold devices and with comparison to the daily use of them the trend observed for complaints with this failure mode is considered to be very low and acceptable.The device was inspected by an arjohuntleigh representative 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.Arjohuntleigh representative informed in incident description form (idf) that used both floor fixings weren't suitable and had come out of the floor.These findings can be confirmed by photos attached to complaint (b)(4).Incident report memo attached to complaint file states that involved malibu bath had recently been uplifted and reinstalled by a third party, and the customer would like to re-install it once again due to the incident.We have not been able to find any contributing manufacturing anomalies.From above findings we conclude that this incident was caused by user error - incorrect re-installation of the device and poor maintenance.The info received and our evaluation as described above determined that if malibu's installation procedures were followed in accordance to assembly and installation instructions and maintenance were followed in accordance to preventive maintenance schedule, there would be no pt or caregiver at risk.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• 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; suite 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3952138
• MDR Text Key: 4643045
• Report Number: 9611530-2014-00037
• 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: Repair
• 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: 05/21/2014
• Initial Date FDA Received: 06/19/2014
• 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