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

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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 events for malibu/sovereign (incl dignity) we have been found low number of other similar cases.We have been able to establish that there is no complaint trend concerning these kinds of events.Please note that arjohuntleigh manufactured over (b)(4) malibu/sovereign (incl dignity) baths to date.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.A "5 why" analysis has been performed in relation to reported incident.Our evaluation showed that the most possible root cause of this event appears to be a user error.Product instruction for use (09.Az.00_2gb from april 2008) provides information about correct and safe use of the product.It informs that user always must make sure that inter alia: "transfer chair seats etc are fastened and all screws tightened." "the resident is sitting calmly and in the middle of the transfer chair during all kinds of transfer." instruction for use provides also information about procedure of transferring the resident, it warns: "before using the transfer chair, always make sure that it is safely attached to the wheel chassis." this warning concerns additional checking of seat during use.In relation to above labeling and above conclusions from capa (b)(4), we can concluded that this situation where seat wasn't seat wasn't check in accordance to warnings included in instruction for use is likely to occur.The most possible cause of this situation is lack or insufficient training.Incident description form informs that date of the last training is unknown and it concerned only presentation how to use bath, no formal training undertaken.From above findings we conclude that this incident was caused by user error - seat wasn't checked before use as recommended in instruction for use (ifu).The received information and our evaluation as described above are showing that if malibu's warnings were followed in accordance to ifu, there would be no patient or caregiver at risk.We have not been able to find any contributing manufacturing anomalies.

• 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: 3939049
• MDR Text Key: 4535123
• Report Number: 9611530-2014-00042
• 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: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1