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

Model Number KMBB4OSU2FUS

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.After review of the reportable complaints for maxi move a number of cases when the hanger bar detached from the t-bar were found.Comparing to the total number of devices sold the complaint ratio is considered to be (b)(6).The device was inspected by an arjohuntleigh representative at the customer site.Due to the reported malfunction (broken pin) 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.It was reported that when the caregivers were lowering resident in the bed, the hanger bar fell off the t-bar.As a consequence of this incident the resident fell onto bed from approximately (b)(6) height and suffered right thumb injury.An x-ray test confirmed no fractures and only ice was applied as a treatment.The spreader bar to t-bar attachment is called the lock & load system in the labelling 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 (part of locking clip) would need to be pushed 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.The guiding pins are parts of the spreader bar, designed to guide the spreader bar onto the t-bar.If they are missing, the shape of the spreader bar will still encapsulate the t-bar like hand-in-fist.It is possible the pin breaks off when treated roughly: having the spreader bar collide with objects.On-label use does not allow for such collisions.The device evaluation confirms paint on scale cover indicating hitting door jams and also scratch on the t-bar which could be the effect of not avoiding obstructions when moving the lift.Instruction for use (ifu, document no.(b)(4), dated on (b)(6) 2006), which was delivered with the device, clearly states how to operate 'lock & load' system properly."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.Warning: check to see that the yoke is locked in place by trying to lift the yoke without pushing in the retaining catch." "warning: before and during operation of the powered dps spreader bar, ensure all obstructions are clear of the spreader bar, support frame and jib." section "care of your maxi move" gives information regarding daily and weekly checks: "check that all external fittings are secure and that all screws and nuts are tight." "general lift condition: carry out a general visual inspection of all external parts, and test all functions for correct operation, to ensure that no damage has occurred during use." the test (b)(4) was performed on (b)(6) 2014 to compare on label use to off label use and the impact of certain malfunctions (including missing guiding pins) to the safe functioning of the maxi move ii.It was concluded that on-label use is very unlikely to cause an event, hazard or injury.Missing guiding pins by themselves are very unlikely to cause an adverse outcome.The only method to simulate spreader bar detachment during use and under load (with the weight of the person in transfer taken on) was to not place it so that it locks into the t-bar, but balance it on top of the t-bar.No other issue appeared likely to cause a drop of the person in transfer before lowering.All simulated scenarios (following the ifu), resulted in observation: "the spreader bar stays firmly in place".From the received information and our evaluation as presented above, user error cannot be ruled out as not correctly engaging spreader bar and its poor condition most likely contributed to the reported event.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

It was reported that when the caregivers were lowering resident in the bed, the hanger bar fell off the t-bar.As a consequence of this incident the resident suffered right thumb injury.An x-ray test confirmed no fractures.

• 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: 5563468
• MDR Text Key: 42386666
• Report Number: 3007420694-2016-00071
• 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: 04/08/2016,03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMBB4OSU2FUS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2016
• Distributor Facility Aware Date: 03/10/2016
• Device Age: 9 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/08/2016
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2007
• 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: 109