MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MAXI MOVE; FSA

Model Number KMBB4PLX2FUS

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab ((b)(4)).As of 2014 that number was deactivated 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 ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).An investigation was carried out into this complaint.When reviewing similar events for maxi move we have found a low number of similar cases where a spreader bar came loose from the lifting arm.With the amount of sold devices and comparison to daily use of a device, we find the occurrence rate since 2010 to be increasing but very low.The device was inspected by an arjohuntleigh representative at the customer site.Due to the reported malfunction it was found to be out of its specification.The device was being used for the patient handling and in that way contributed to the reported event.This spreader bar (that holds the sling and patient) to t-bar (that connects to the lift device) attachment is called the "lock & load system" in the labeling of the device.The lock & load system is designed so that, when the spreader bar is connected to the t-bar, only a manual lifting of the spreader bar would allow separation of the spreader bar.Furthermore, during this manual lifting of the spreader bar, a secondary component called the retaining catch would need to be manipulated in order to allow for the separation.This retaining catch is designed to prevent an inadvertent separation of the spreader bar due to an unintended upward force applied to the spreader bar.This complaint concerns an event where a resident was transferred from a wheelchair to a bath.In this transfer situation the most likely circumstance for the separation of the spreader bar from the lift device would be that the spreader bar was lowered onto a solid object when lowering down, with the lock & load system not engaged correctly.No significant obstructions were noticed during visit at the customer.However it is most likely that the wheelchair could contribute to the detachment - e.G.: lowered onto chair's arm rests and the user to keep pushing handset down button.The received information showed that there was only one malfunction with the spreader bar: broken positioning pin, however our use simulations showed (test report (b)(4)) that it is not likely that a missing pin could have caused or contributed to the spreader bar's detachment.In accordance to the service technician the facility was aware about missing/broken off positioning pin.The examination of the device confirmed also that locking clip was working normally.However it was possible to re-create the reported event.This situation was re-produced "if jostled slightly" what is still off-label use.It is therefore concluded most likely that the lock & load system was not engaged correctly as the patient was being positioned onto bed because the spreader bar was inadvertently separated from the t-bar when lowered down and because this went unnoticed as the patient was being lifted off the surface before the transfer.The scenarios presented above are part of our use simulation.The product instruction for use (ifu) is attached with each device.Ifu (04.Km.00/2us from august 2006) informs how to disengage and install spreader bar: "to remove an existing attachment, hold the unit carefully.To release, push in the retaining catch on the attachment yoke.Then lift the yoke upwards and away from the carrier.Store carefully for future use.Select the required attachment.Then carefully lift the unit up and allow the recess in the yoke to fit around the carrier shaft.Ensure the yoke drops down over the carrier and the retaining catch engages".It warns also: "check to see that the yoke is locked in place by trying to lift the yoke without pushing in the retaining catch".For this procedure ifu warns: "before and during operation of the powered dps spreader bar, ensure all obstructions are well clear of the spreader bar, support frame and jib".In 'care of your maxi move' section instruction for use informs about daily checks, it includes: "check that all external fittings are secure and that all screws and nuts are tight.From the received information and our evaluation as presented above, use error cannot be ruled out as not correctly engaging spreader bar and its poor condition most likely contributed to the reported event.It is also considered likely that spreader bar was lowered onto rigid surface (chair) and incorrectly attached spreader bar was pushed upwards.This is in line with other similar reportable complaints and our test simulations.The received information and our evaluation as described above are showing that if maxi move's handling procedures were followed in accordance to instruction for use, there would be no patient or caregiver at risk.The device was not to specification, was used for patient handling and due to its condition and likely due to use error contributed to the outcome of the event.

Event Description

Initially it was reported to arjohuntleigh representative that spreader bar detached during use: "while raising the jib during a 2-person transfer from a wheelchair to the bed, the hanger bar detached and grazed the right temporal area of the resident's head.During this event, there were no injuries to the resident or caregivers present.The facility's physical therapist was present at the time of this transfer behind the wheelchair and saw the detachment early enough to catch the falling hanger bar before an injury occurred".

• Brand Name: MAXI MOVE
• Type of Device: FSA
• 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: 5430587
• MDR Text Key: 38032873
• Report Number: 3007420694-2016-00019
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/11/2016,01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMBB4PLX2FUS
• 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: 02/11/2016
• Distributor Facility Aware Date: 01/14/2016
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/11/2016
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2008
• 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 Age: 90 YR
• Patient Weight: 62