MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI MOVE; LIFT, PATIENT, NON-AC-POWERED

Model Number KMCSAN

Device Problem Detachment Of Device Component (1104)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

On 2018-03-06 arjohuntleigh has become aware of an event which occurred with the involvement of a maxi move passive floor lift at (b)(6).While a resident was being transferred from a bed to a wheelchair, the spreader bar detached from the lift and fell on with patient on the floor.As consequence of the event the patient sustained serious injury (occipital hematoma and excoriation, fracture of the sacral wing).Information provided to a complaint indicates that: the last preventive maintenance of the device was performed in (b)(6) 2017.The lift was inspected by arjo representative.The photographic inspection shows that one of two guiding pins was broken off.

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events, we have found a number of cases with similar fault description, when the spreader bar detached from lifting arm of the device.On 2018-03-06 arjohuntleigh has become aware of an event with the involvement of a maxi move passive floor lift at apsp cementino vannetti, rovereto , italy.While a resident was being transferred from a bed to a wheelchair, the spreader bar detached from the lift and fell on the ground with a patient.As consequence of the event the patient sustained a serious injury (occipital hematoma and excoriation, fracture of the sacral wing).The last preventive maintenance of the device was performed on 2018-08-31 by arjo.After the incident, the lift was inspected by arjo representative.The inspection showed that one of two guiding pins was broken off.The spreader bar to t-bar attachment is called the lock & load system in the labeling of the maxi move lift.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 (detachment) 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 (locating) pins are parts of the spreader bar, designed to guide the spreader bar onto the t-bar.If they are missing, bent or damaged, 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.Please note that on-label use of the device does not allow for such collisions.The maxi move instruction for use (ifu) is provided with each device.Ifu (001.25060 rev.4, april 2010) informs how to install spreader bar in safe and correct way: "to install an attachment: select the attachment required and - while carefully handling it, with the locking clip thumb pads facing you - allow the recess in the attachment to fit around the t-bar shaft.Ensure the attachment drops down over the t-bar and that the locking clip engages fully." (p.16).The ifu also warns: "always check that the attachment is locked in place by: 1) verifying the markings on the attachment that show that there is a proper alignment, and 2) verifying that the locking clip is fully engaged, thus ensuring that the attachment is securely fastened." (p.17) "do not lower the attachment onto rigid surfaces (e.G.Bed, floor, wheelchair armrests, etc., to avoid the possibility of the attachment becoming dislodged from the t-bar.A dislodged attachment may later detach completely from the unit, causing the patient to fall." (p.17).The device has a design that clearly shows to the user when the spreader is and when it is not correctly engaged.A smiley face appears when the spreader bar is locked in place correctly.However, it was found under internal simulation that, under special conditions, if one guiding pin is missing, the smiley face is present, but the locking clip could potentially be ineffective if a certain sequence of events takes place.This involves a situation where: transfer is at the initial phase (at the time of lifting the resident up from the bed) the dps is unloaded (it is suspected that the resident's body weight did not fully load the spreader bar).The one of guiding pins is missing (confirmed upon the device inspection).The spreader bar is lowered onto an object (such as wheelchair arm) (there was a wheelchair involved in the event).The dps topples over (confirmed upon the device inspection).Following a description of the reported event, it corresponds to sequence of events described above.This failure is easy to be recognized by the user if the lift is visually checked as required by the instructions for use (daily check to inspect external fittings is indicated to be mandatory in the care section of the ifu).Also, as per ifu, the user is obliged to check that the spreader bar is locked in place by trying to lift it without unlocking the locking mechanism.When the locking mechanism is broken, when the lock does not catch for other reasons or when the spreader bar is balanced on top of the t-bar -possibly in combination with broken pins or other malfunctions and use errors- and the spreader bar is lowered onto an object (e.G.Bed, chair), the spreader bar will only topple over when it is pushed up and not held into position by the weight of the person in transfer, and not held back by an attached sling.In that case the spreader bar will topple away from the face of the person.Patient or user is not in any immediate danger and is not exposed to a risk to health, as long as the device is used according to labeling and in particular the spreader bar is correctly attached and checked to be locked in place before each transfer.Based on product knowledge, description of the event and review of similar situations that took place in the past, the spreader bar detachment failure can occur only when a user did not follow correct transfer procedure as presented in the device labeling.To conclude, arjohuntleigh maxi move passive lift played a role in the complaint issue when the event occurred as it was used for resident's transfer.Although device did not meet its performance specification because the spreader bar's locking pin was broken, these malfunction did not affect directly the spreader bar failure.We report this event to competent authorities due to fact that patient sustained serious injury.

Manufacturer Narrative

The follow up report was created to correct information from previous report.The device guiding pins were bent insted off broken off as it was indicated in the previous report.Please refer to corrected report below: an investigation was carried out into this compliant.When reviewing similar reportable events, we have found a number of cases with similar fault description, when the spreader bar detached from lifting arm of the device.On (b)(6) 2018 arjohuntleigh has become aware of an event with the involvement of a maxi move passive floor lift at apsp cementino vannetti, rovereto , italy.While a resident was being transferred from a bed to a wheelchair, the spreader bar detached from the lift and fell on the ground with a patient.As consequence of the event the patient sustained a serious injury (occipital hematoma and excoriation, fracture of the sacral wing).The last preventive maintenance of the device was performed on 2018-08-31 by arjo.After the incident, the lift was inspected by arjo representative.The inspection showed that one of two guiding pins was bent.The spreader bar to t-bar attachment is called the lock & load system in the labeling of the maxi move lift.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 (detachment) 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 (locating) pins are parts of the spreader bar, designed to guide the spreader bar onto the t-bar.If they are missing, bent or damaged, 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.Please note that on-label use of the device does not allow for such collisions.The maxi move instruction for use (ifu) is provided with each device.Ifu (001.25060 rev.4, april 2010) informs how to install spreader bar in safe and correct way: "to install an attachment: select the attachment required and - while carefully handling it, with the locking clip thumb pads facing you - allow the recess in the attachment to fit around the t-bar shaft.Ensure the attachment drops down over the t-bar and that the locking clip engages fully." (p.16).The ifu also warns: "always check that the attachment is locked in place by: verifying the markings on the attachment that show that there is a proper alignment, and verifying that the locking clip is fully engaged, thus ensuring that the attachment is securely fastened." (p.17) "do not lower the attachment onto rigid surfaces (e.G.Bed, floor, wheelchair armrests, etc., to avoid the possibility of the attachment becoming dislodged from the t-bar.A dislodged attachment may later detach completely from the unit, causing the patient to fall." (p.17).The device has a design that clearly shows to the user when the spreader is and when it is not correctly engaged.A smiley face appears when the spreader bar is locked in place correctly.However, it was found under internal simulation that, under special conditions, if one guiding pin is missing, the smiley face is present, but the locking clip could potentially be ineffective if a certain sequence of events takes place.This involves a situation where: transfer is at the initial phase (at the time of lifting the resident up from the bed) the dps is unloaded (it is suspected that the resident's body weight did not fully load the spreader bar) the one of guiding pins is missing or bent(confirmed upon the device inspection) the spreader bar is lowered onto an object (such as wheelchair arm) (there was a wheelchair involved in the event).The dps topples over (confirmed upon the device inspection).Following a description of the reported event, it corresponds to sequence of events described above.This failure is easy to be recognized by the user if the lift is visually checked as required by the instructions for use (daily check to inspect external fittings is indicated to be mandatory in the care section of the ifu).Also, as per ifu, the user is obliged to check that the spreader bar is locked in place by trying to lift it without unlocking the locking mechanism.When the locking mechanism is broken, when the lock does not catch for other reasons or when the spreader bar is balanced on top of the t-bar -possibly in combination with broken pins or other malfunctions and use errors- and the spreader bar is lowered onto an object (e.G.Bed, chair), the spreader bar will only topple over when it is pushed up and not held into position by the weight of the person in transfer, and not held back by an attached sling.In that case the spreader bar will topple away from the face of the person.Patient or user is not in any immediate danger and is not exposed to a risk to health, as long as the device is used according to labeling and in particular the spreader bar is correctly attached and checked to be locked in place before each transfer.Based on product knowledge, description of the event and review of similar situations that took place in the past, the spreader bar detachment failure can occur only when a user did not follow correct transfer procedure as presented in the device labeling.To conclude, arjohuntleigh maxi move passive lift played a role in the complaint issue when the event occurred as it was used for resident's transfer.Although device did not meet its performance specification because the spreader bar's locking pin was bent, these malfunction did not affect directly the spreader bar failure.We report this event to competent authorities due to fact that patient sustained serious injury.

• Brand Name: MAXI MOVE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, ; CA
• MDR Report Key: 7391426
• MDR Text Key: 104141031
• Report Number: 9681684-2018-00025
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: KMCSAN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2018
• Distributor Facility Aware Date: 03/06/2018
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/23/2018
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 04/03/2018
• Supplement Dates FDA Received: 04/13/2018; 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 42