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

Device Problems Use of Device Problem (1670); Device Operational Issue (2914); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Pain (1994); Injury (2348)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar events for malibu/sovereign (incl.Dignity) we have found low number of other similar cases.We have been able to establish that there is no complaint trend concerning these kind of events.(b)(4).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 patient handling and in that way contributed to the event.We have not been able to find any contributing manufacturing anomalies.From above findings we conclude that this incident was caused by user error - poor maintenance: handset was showing signs of wear and wasn't functioning correctly.Therefore, it should have been replaced and not used with patient.The received information and our evaluation as described above are showing that if malibu's maintenance was followed in accordance to preventive maintenance schedule, there would be no patient 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; ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3908482
• MDR Text Key: 4581556
• Report Number: 9611530-2014-00034
• 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: 05/08/2014
• Initial Date FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1