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

Model Number KMCSUN

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 08/16/2017

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 that during transfer of the resident from bed to wheelchair with maxi move lift and sling, resident slipped out of the sling and fell on the floor.During the transfer, only one caregiver was attending for the transfer and extra large passive sling was applied.Additionally, it was informed that resident has been sized for a medium size of the sling by the facility.

Manufacturer Narrative

This report is being filed under exemption e2012068 by the arjohuntleigh magog inc.(registration # (b)(4)) on behalf of the importer (b)(4) (registration # (b)(4)).On (b)(6) 2017 arjohuntleigh received customer complaint that during transfer of the resident ((b)(6) old, (b)(6), female) from bed to wheelchair with maxi move lift and sling, resident slipped out of the sling and fell on the floor.During the procedure of transfer, only one caregiver was attending and the extra large passive sling was applied.Additionally, it was informed that resident has been sized for a medium size of the sling by the facility.Fortunately, no serious injury occurred.As a consequence of the event resident sustained a hematoma on left posterior side of the head.When reviewing similar reportable events, we have found a very low number of cases with similar fault description ( the wrong size of the sling used).The occurrence rate observed for reportable complaints with this failure mode is currently considered to be very low and stable.No malfunctions regarding the maxi move lift as well as sling were reported that could have caused or contributed to the event.From the information received it appears most likely that the resident slipped out of sling due to the wrong size of the sling used for transfer - too large sling.An extra large sling which was involved in the incident can be used with a person in a weight range between 140-200 kg.Therefore, we can state that the sling used with the resident was approximately three sizes too big.The patient's weight was indicated to be (b)(6) and therefore a medium size of the sling should be used with this resident.It is possible for a person to slip out of a sling that is of a very inappropriate size (several sizes off).In this case, it appears quite possible that for example the gap between the leg straps is so big that the body of the person will slide out entirely at the bottom of the sling.This is not likely to occur when there is only one size difference as the gap would not be big enough - at least should all other instructions in the ifu be followed.Following the maxi move instruction for use (ifu) supplied with the lift: "warning: before lifting a patient, a clinical assessment of the patient's condition and suitability to be lifted should be carried out by a qualified professional considering that, among of other things, the transfer may induce substantial pressure on the patient body." "a label is placed on the spreader bar for a quick color-to-size reference" "the need for a second attendant to support the patient must be assessed in each individual case." to conclude, maxi move lift and clip sling were used for patient's care and in this way contributed to the alleged event.No defect has been found, but since the slipped out of sling was indicated, it can be stated that the system did not meet its performance specification.No serious adverse event occurred.We report this event to competent authorities as falling to the floor may result in serious injury if would recur.Arjohuntleigh suggests to remind the involved customer facility staff about the device labeling, with special attention to assessment of a resident's size before selecting the proper size of the sling to prevent the similar incident from re-occurring.

• 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: 6885722
• MDR Text Key: 89380514
• Report Number: 9681684-2017-00073
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMCSUN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Distributor Facility Aware Date: 08/25/2017
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/20/2017
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2011
• 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: 70 YR
• Patient Weight: 55