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

Model Number KMCLUN

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 arjohuntleigh received customer complaint where it was reported that during the transfer process with maxi move lift and sling, leg sling clip detached from spreader bar of lift and resident fell to floor.Resident was sent to hospital, details regarding injury are unknown at this time.No malfunctions regarding lift, as well as sling were indicated.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information gathered it appears most likely that the incident occurred during the beginning of resident's transfer with maxi move lift and sling.It was indicated that a clip sling detached from the spreader bar of the lift and resident fell on the floor.Initially, it was reported that resident (female, (b)(6) years old) was hospitalized.However, following the additional information received, no serious injury occurred.Resident sustained a bruise and scratches on right back shoulder as a consequence which did not require a medical intervention nor hospitalization.When reviewing similar reportable events, we have found a number of cases with similar fault description (clip detachment).The trend observed for reportable complaints with this failure mode is currently considered to be low and stable.It has been established that the lift device (maxi move) and the clip sling system was being used for patient handling at the time of the event and in that way contributed to the outcome of the event.The sling and the lift device were inspected.It was found was that the lift's mast support attachment screw was slightly loose.However, this has not impacted on the performance of the lift when using according to the ifu.No malfunctions were found that could have caused or contributed to the event.It can be established that the sling and the lift were being used for patient handling but it appears it contributed to the event possibly due to a use error.A sling clip, once correctly attached and monitored to stay in place as the weight of the person in the sling is gradually taken up, as indicated to be required in the labeling, is locked in position with the weight of the patient.It is not likely to come off during on label use.During the clip detachment, the person is likely to fall away from the sling, toward the corner where the clip is not in place as shown in our simulations.We know that in the situation, when the clip is not attached and under tension with the weight of the person in the sling from the start, a drop will be immediate.The only exception being: when a person is lifted from a horizontal position and a leg clip is not attached.A person can be lifted from a horizontal position with one of the leg clips not in place.However, typically when the patient is at the end of that transfer, put into a more upright, seated position, the weight shifts towards the missing clip strap and the person falls out.Following the above scenario, it appears most likely that the clip was not in place at the start of the lifting procedure and could wiggle off when the patient was put into a more upright position.There is a possibility that certified nursing assistants (cnas) did not follow the labelling and did not check the clips, if those are correctly attached and remain in tension, as the weight of the resident is gradually taken up.Per labelling, the user is obliged to monitor the clips becoming under tension when the weight of the patient is gradually being loaded on.The maxi move lift instructions for use (ifu) supplied with the lift contains crucial information: "warning: important: always check that the sling attachment clips are fully in position before and during the commencement of the lifting cycle, and in tension as the patient's weight is gradually taken up" from this evaluation it would appear most likely that the event was caused by the user not following the ifu, due to lack of awareness of the ifu contents.Note that the customer was visited and interviewed by a local arjohuntleigh representative.Arjohuntleigh suggests to remind the staff involved of the device labelling, with special attention to correct lifting procedure.We find this complaint to be reportable to the competent authorities.

Event Description

On (b)(6) 2017 arjohuntleigh received customer complaint where it was reported that during the transfer process with maxi move lift and sling, sling clip detached from spreader bar of lift and resident fell to floor.Initially, it was reported that resident was hospitalized.However, following the additional information received, no serious injury occurred.Resident sustained a bruise and scratches on right back shoulder as a consequence which did not require a medical intervention nor hospitalization.

• Brand Name: MAXI MOVE
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 6803020
• MDR Text Key: 82982534
• Report Number: 9681684-2017-00061
• 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: 09/22/2017

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?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMCLUN
• 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: 09/22/2017
• Distributor Facility Aware Date: 07/24/2017
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/22/2017
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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; Other
• Patient Age: 91 YR