MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 2; LIFT, PATIENT, NON-AC-POWERED

Model Number MS110-01-01

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problems Abrasion (1689); Injury (2348)

Event Date 05/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the manufacturer's investigation.

Event Description

On (b)(6) 2018 arjo has become aware of the event involving maxi sky 600 ceiling lift and a loop sling, which occurred in (b)(6), usa.It was reported that during repositioning of the lift hanger bar (as the sling was caught on the broda chair), the sling loop slipped out of the hanger bar and resident fell.As a consequence, the resident sustained injury requiring surgical intervention.

Manufacturer Narrative

On 2018-jan-15 arjo has become aware of the event involving ceiling lift and a loop sling, which occurred in (b)(6) health care center, located in (b)(6), usa.Initially the customer provided a powerpoint presentation, which was considered to be a description of the event.Upon the visit at the customer site, arjo representative received different information than those presented in the presentation and are the subject of this investigation.Further clarification revealed that information presented in a powerpoint presentation was already documented and reported under 9681684-2010-00013 medwatch report.It was reported that the patient (male, (b)(6)) was being transferred from wheelchair to bed using toilet sling (mla4031-xl) in a sitting position (green loops attached on both shoulder and leg straps to the hanger bar) with support belt and the buckles attached.While the patient was in air, he reached and grabbed the lift's 2 point hanger bar.He was told to put his arms across chest and at that time the left buckle joining the neck section and midsection came loose.Then the right shoulder green loop detached from the hanger bar.The patient was lowered, no fall occurred.He bumped his head and sustained a small abrasion behind the right ear.He was taken to the emergency room.The cat scan and routine tests were performed with negative results.The support belt around the patent's midsection was attached and the customer indicated that its application prevented the resident from falling.Both the maxi sky 2 ceiling lift and toilet sling were inspected by arjo representative.No malfunction within the sling, neither lift that could have caused or contributed to the loop detachment was reported.Based on this reported information and our product knowledge, the possibility that a sling was not attached at all as well as the possibility that the sling was properly attached within the spreader bar hooks when the resident was lifted is considered to be highly unlikely.The cause of the detachment of the sling is an incorrect sling installation and/or manipulation of the lift.The straps are prompt to detach during the early lifting of the patient and detach as soon as the tension is applied to the straps or during the manipulations prior the lifting.It was indicated that resident reached and grabbed the hanger bar, what could cause the spreader bar to tilt and the loop to become unloaded and slip out the spreader bar.Therefore, it is considered that the loop was improperly attached when the patient was lifted, and suddenly detached later on during the transfer or the loop detached due to being unloaded and the spreader bar tilt during the transfer because of the patient grabbing the spreader bar.The safety practices included in the toilet sling instructions for use (ifu, 04.St.00-int1_2) states: "at any time, if the resident becomes agitated, stop transferring/transporting and safely lower the resident." the maxi sky 2 ifu (001-15698-en-rev.4) describes the proper transfer procedure including guiding the spreader bar during transfer procedure with hand: "proceed with the transfer keeping a hand on the spreader bar to stop excessive swinging and to give a feeling of added security." what is more, the transfer was performed from wheelchair to bed and the patient was told to release the hanger bar and put his arms across chest.The toilet sling ifu clearly indicates that arjo toilet sling should not be used for lifting and transportation apart from toilet visits and that the resident's arm should be placed outside the sling.When reviewing reportable complaints on maxi sky 2 registered during the last 5 year with similar fault description (loop detachment), we have found no other reportable complaint.To conclude, maxi sky 2 lift and toilet loop sling were used for patient's care at the time of the event occurrence and only from that perspective they contributed to the alleged event.Since falling through sling was indicated, it can be stated that the system did not meet its performance specification.We report this event to competent authorities due to potential of serious injury.

Event Description

It was reported that the patient (male, (b)(6) ) was being transferred from wheelchair to bed using toilet sling (mla4031-xl) in a sitting position (green loops attached on both shoulder and leg straps to the hanger bar) with support belt and thr buckles attached.While the patient was in air, he reached and grabbed the lift's 2 point hanger bar.He was told to put his arms across chest and at that time the left buckle joining the neck section and midsection came loose.Then the right shoulder green loop detached from the hanger bar.The patient was lowered, no fall occurred.He bumped his head and sustained a small abrasion behind the right ear.He was taken to the emergency room.The cat scan and routine tests were performed with negative results.The support belt around the patient's midsection was attached and the customer indicated that its application prevented the resident from falling.

• Brand Name: MAXI SKY 2
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 7663150
• MDR Text Key: 113159037
• Report Number: 9681684-2018-00056
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS110-01-01
• 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: 08/01/2018
• Distributor Facility Aware Date: 06/15/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2018
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• 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): Other; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 113