MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 600; LIFT, PATIENT, NON-AC-POWERED

Model Number LD10019

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, the arjo representative was informed about the incident related to arjo maxi sky 600 ceiling lift.As per customer's event description, the spreader bar detached from the lifting strap causing fall of the resident and the spreader bar from height about 100 cm.As a consequence of the fall the resident sustained fractures to pelvis and ribs.Injured required a medical intervention and was hospitalized by 8 days.

Manufacturer Narrative

On (b)(6) 2018, the arjo representative was informed about the incident involving arjo maxi sky 600 ceiling lift.As per customer's event description, the spreader bar detached from the lifting strap causing fall of the resident and the spreader bar from height about 100 cm.As a consequence of the event the resident sustained fractures to pelvis and ribs.Injured required a medical intervention and was hospitalized for 8 days.The spreader bar dedicated for maxi sky 600 should be attached to the end of the ceiling lift strap by special connection located in a spreader bar union tube.The strap attachment pin is fitted through the spreader bar socket and lift strap, and next it is secured by ring inserted through the hole in the pin to avoid its disconnection during use.Instruction for use (001.14150.33.En-rev.15) informs the user that before every use, the caregiver must always ensure that the strap attachment pin is re-fitted correctly through the spreader bar socket and lift strap, and that the securing ring is correctly inserted through the hole in the pin.The ifu includes the images showing the adequate and inadequate attachment of the spreader bar to the ceiling lift strap and allowed the combination of the spreader bars.The customer was visited by arjo representative on (b)(6) 2018.During evaluation of the involved device, it was established that the lift was used with spreader bar model number 700-19480, serial number 300197410 equipped with a quick connection mechanism.Please be aware that used spreader bar is not compatible with maxi sky 600 ceiling lifts and is not recommended to be used with maxi sky 600 ceiling lift device, as per device labeling.It was attached to the lift by 3rd part company installer (rehab and mobility systems in clio, mi) who replaced the original strap attachment pin on another one (from different ceiling lift device) to build unapproved connection to connect the no compatible spreader bar to the ceiling lift.When reviewing similar reportable events registered in the last 5 years, we have not found any similar complaint related to the investigated issue.According to that, this particular complaint appears to be an isolated occurrence.Sum up, while the incident occurred the device was being used for patient's handling.The device was not according to the manufacturer's specification because of unauthorized modification of the connection between the spreader bar and the lifting strap that was made by the third party service provider.The correct spreader bar has been already ordered for this customer.The complaint decided to be reportable based on the actual outcome of the incident - the resident received serious injury.

• Brand Name: MAXI SKY 600
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• MDR Report Key: 7457339
• MDR Text Key: 106382996
• Report Number: 9681684-2018-00034
• 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
• Report Date: 04/27/2018

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: Patient Family Member or Friend
• Device Model Number: LD10019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Distributor Facility Aware Date: 04/10/2018
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 91