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

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for malibu/sovereign (incl.Dignity), we haven't found any of other similar cases where shower handle dropped to the pt and caused injury.We have been able to establish that there is no complaint trend concerning these kind of events.Arjohuntleigh manufactured over (b)(4) malibu/sovereign (incl.Dignity) baths to date.The device was inspected by an arjohuntleigh rep at the customer site and found to be out of its specification.The device was being used for pt handling and in that way contributed to the event.Info provided in complaint (b)(4) (parent record of this investigation) confirm that shower handle didn't securely lock into quick release coupling, therefore, if preventive maintenance was correctly performed, faulty parts should be replaced and there would be no pt at risk.Further device examination showed also that complained malibu bath wasn't correctly secured to the floor - retaining bracket was loose on fixing, also there was crack in front panel.Previous service has been performed only by the customer in (b)(6) 2014, therefore, it can be stated that it wasn't performed correctly.Please note also that this bath was in use for over 10 yrs.From above findings, we conclude that this incident was caused by a combination of user error - poor or lack of maintenance, faulty parts weren't replaced as recommended by the mfr, customer didn't preserved safety of the device and used it with damaged parts, and normal wear - bath was in use for over 10 yrs.We have not been able to find any contributing mfg 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 ; 2103170412
• MDR Report Key: 3737936
• MDR Text Key: 16057175
• Report Number: 9611530-2014-00021
• 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: Consumer,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: 02/25/2014
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2002
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1