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

Model Number AZR31114-GB

Device Problems Break (1069); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previously medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment (b)(4).As of 2014 that number was de-activated due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under arjohuntleigh (b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for malibu/sovereign we haven't found any other similar complaint where tub was tipping because of broken weld at base frame.We have been able to establish that there is no complaint trend that concerns these events.Arjohuntleigh manufactured over (b)(4) malibu/sovereign baths to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of the specification - cracked weld and bath's movement.The device was being used for patient handling and in that way contributed to the event.Instructions for use (ifu) is provided with each device.Ifu (04.Zz.00/1gb from december 2005) provides information about preventive maintenance that should be carried out in intervals recommended in ifu.In accordance to it: caregiver is obliged to perform functionality test every week - test all functions including lifting function; qualified personnel is obliged to check all vital parts for corrosion and damage and perform a safe working load test every year.Please note that last maintenance was performed in 2010 and involved device is not under any service contract since this time.No service records are available.From the review of received information, provided photos and video, we can conclude that this problem is also related to worn out equipment.Water marks were found at the frame, but no signs of corrosion were found.The root cause for this incident is chassis with broken welds.After performing tests for similar complaint ((b)(4)) have we come to the conclusion that a bath with two broken welds would not tip even if we repeatedly swung the lift arm and chair which is loaded with maximum swl (130 kg), outside the bath.It is also, according to us, impossible not noticing the abnormal deformation/flexibility caused by the weight on the chair (and the broken legs on the chassis) if the customer is using the tub.We can conclude that the most likely cause for weld breakage is excessive use of the device e.G.: exceeding safe working load (swl), abusive use of lifting unit.From above findings we find this problem to likely related to: user error - lack of poor maintenance, as showed in idf last maintenance was performed in 2010, it is unknown if any other service was performed since this time; worn out equipment - as showed in test report, it is likely to notice this problem before use, please note that this device was in use for over 6 years.

Event Description

Initially it was reported by arjohuntleigh representative that tub was tipping during use.User was in the overhead ceiling hoist, being lowered onto the malibu bath chair that was outside the bath.As the user was being lowered, the bath/chair was taking the full weight of the user, and then there was a snapping/bang noise and the bath tilted as the users full weight was applied.The bath was also full with water.No injury occurred as a result of this incident to the resident or caregiver.User was secured in a sling attached to a ceiling lift.Device examination included in incident description form (idf) showed that general condition of involved bath is good, only some cosmetic damage.Function test showed that bath is working correctly.Only when arjohuntleigh's representative applied weight to the chair while it was outside the tub, he found a lot of movement, on closer inspection, it was found that the welds holding the upright supports to the frame had snapped.Last maintenance was performed in 2010, currently bath is not under any service contract, therefore no latest service records are available.Additionally provided information: 11/20/2014 "the bath is secured firmly to the floor - with no signs of movement.".

• Brand Name: MALIBU/SOVERIGN (INCL. DIGNITY)
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4339579
• MDR Text Key: 51035288
• Report Number: 3007420694-2014-00125
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/05/2014,11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AZR31114-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2014
• Distributor Facility Aware Date: 11/14/2014
• Device Age: 6 NA
• Event Location: Home
• Date Report to Manufacturer: 12/05/2014
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 90