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

Model Number KMCSUN

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

Patient Problems Fall (1848); Laceration(s) (1946); Injury (2348)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to arjohuntleigh that the patient fell out of sling during transfer from bed to chair with maxi move passive floor lift.The event occurred at the moment of detaching the sling from spreader bar by assisting caregiver.The involved patient sustained laceration and was hospitalized.

Manufacturer Narrative

An investigation was carried out into this complaint.On 2017-aug-10 arjohuntleigh has become aware of an incident reported by (b)(6).It was alleged that during a resident transfer with maxi move passive floor lift from bed to chair, a sling clip detached from a spreader bar causing resident to fall.As a consequence of the event, the resident sustained a head laceration - the injury required stiches to be applied.The injury has been assessed as serious.The involved resident was taken to hospital for further assessment.It was indicated that the resident might have also sustained a neck injury because of the fall.The x-ray picture was taken, but it was not possible to assess if it was a preexisting injury or it was caused directly by this incident.When reviewing similar reportable events registered within last 5 years, we have found a number of cases with similar fault description (sling clip detachment).If compared to the number of sold devices and in comparison to their daily usage, the occurrence rate for reportable complaints claiming this failure mode is considered to be low.The system (consisting of maxi move passive floor lift and passive sling) was inspected by arjohuntleigh representative.There was no malfunction with the sling detected (the minor stains were found).The lift was in overall good condition and showed signs of normal wear and tear - scratches on chassis, legs and mast and the damage of top of the jib cover were noticed.In course of the investigation it has been tried to establish the most likely root cause of the reported incident - sling clip detachment from spreader bar causing the resident fall and head laceration.A sling clip, once correctly attached and monitored to stay in place by caregivers as the weight of the person in the sling is gradually taken up, as indicated to be required in the labelling, is locked in position with the weight of the patient.It is not likely to come off during on-label use.It cannot go inward because it is stopped by the metal frame of the spreader bar.It cannot go outward because it is stopped by the metal end stop of the clip attachment lug.It cannot go downward as it is suspended on said clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient."important: always check that all the sling attachment clips are fully in position before and during the lifting cycle, and in tension as the patient's weight is gradually taken up." it is worth noting that no malfunction with the sling, neither lift that could have caused or contributed to the clip detachment was detected upon their inspection.When the clip becomes detached, the person is likely to fall away from the sling towards the corner where the clip detached: 1) if the leg clip is not attached but a resident weight is applied to it during initial stage of resident transferred onto the sling, a drop can be immediate if there is no chair that could prevent the further fall.If the labeling is followed the possibility of occurrence such hazardous situation is minimal.However, it is possible for the caregivers to not follow the instruction provided in the device labeling in regards to checking if the clips are correctly attached and remain in tension as the weight of the resident is gradually taken up.The user is obliged to monitor the clips becoming under tension when the weight of the patient is gradually being loaded on.This scenario is unlikely to occur in this incident as it was confirmed by the facility staff that the resident transfer was already in progress.2) there are additional scenarios, which also involve usage of the device, which is not in accordance to ifu.During transfer the resident must be turned in the correct direction.As a result the caregiver must manipulate the spreader bar that holds the sling and is able to turn for this purpose.The intended and labeled use is that this occurs by operating and manipulating the spreader bar itself, and not the sling nor the person in the sling.If this labeling is followed the possibility of occurrence of hazardous situation is minimal.However, it is possible for the caregiver to not follow the labeling and use the person in the sling to manipulate the spreader bar.In this case the clip could be inadvertently pulled off by the caregiver while using the sling or the person in the sling for repositioning.This scenario can correspond to the description of the reported event - the clip detachment in process of transfer.Consequently to the above, we come to the conclusion that the event was most likely caused by use error, based on the customer information and the simulations performed previously based on earlier incidents.The facts that there was no malfunction of the device found and the event could not have been duplicated also lead to the conclusion that the incident was caused the most likely by use error.The labelling for the lift device indicates the system should be used by trained personnel that are aware of the ifu contents.Arjohuntleigh suggests reminding the staff involved of the device labelling, with special attention to correct lifting procedure and checking the sling and the lift before transfer.This is to be communicated to the customer.Taking into account the listed above facts, it is found the device was being used for patient handling when the event occurred and it was also directly involved with the adverse event as a serious injury occurred.There was no technical malfunction with the lift, neither the involved sling detected.

• Brand Name: MAXI MOVE
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, ; CA
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6819783
• MDR Text Key: 83607596
• Report Number: 9681684-2017-00063
• 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
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

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: KMCSUN
• 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: 09/26/2017
• Distributor Facility Aware Date: 08/10/2017
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/26/2017
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2014
• 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): Hospitalization
• Patient Weight: 50