MAUDE Adverse Event Report: ARJOHUNT LEIGH MAGOG INC MAXI SKY 600

Model Number LD10319

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

Patient Problem Fall (1848)

Event Date 05/03/2015

Event Type  Injury  

Event Description

On 05/08/2015 the following was reported to arjohuntleigh: on (b)(6) 2015 during the pt's transfer from a bed to a commode using maxi sky 600 ceiling lift the loop of a disposable sling came unhooked and the pt fell to the floor hitting her head.It was indicated that the pt was then hospitalized.No other info was released.On (b)(6) 2015 an on-site visit at the customer site was performed by arjohuntleigh rep and add'l comments regarding the event from facility personnel indicates that the "resident was discharged on (b)(6) 2015".

Manufacturer Narrative

(b)(4).Arjohuntleigh received a customer complaint where it was indicated that during the pt's transfer using ceiling lift the pt fell out from the disposable loop sling due to detachment of one of the sling loop.An investigation was carried out regarding this incident.When reviewing similar reportable events, we have found a number of cases with similar fault description (loop detachment).The trend observed for reportable complaints with this failure mode is currently considered to be relatively low and stable.The maxi sky 600 ceiling lift and the disposable "flite" sling were inspected and no malfunctions were found that could have caused or contributed to the event.Therefore, the sling and the ceiling lift which work together as a system were found to have been to spec when the event took a place.The sling and the ceiling lift were being used for pt care when the event took place and in that way contributed to the outcome of the event.A drill-down analysis was conducted into this event.From the sequence of event, it must be noted that the detachment occurred as the pt was in the air - was being transferred from bed to a commode when the sling loop came off.Based on this reported info, the possibility that a sling was not attached at all when the pt was lifted is considered highly unlikely, as this would result in the pt sliding out immediately when she would be lifted off the bed.Also, the possibility that the sling was properly attached within the spreader bar hooks is considered highly unlikely.The disposable "flite" sling includes four straps which all remain under tension during the transfer, so the possibility that the loop would be lifted upward and would come off the hooks while under tension is improbable.Therefore, it is considered that the loop was improperly attached when the pt was lifted, and suddenly detached later on during the transfer.Following info received it appears most likely that sling loop was improperly attached when the pt was being lifted as the caregiver did not notice the inadequate attachment during transfer, which constitutes an user error.We find this event's root cause to be related with lack or insufficient training.Note that the customer was visited and interviewed by a local arjohuntleigh rep but could no provide any training dates for staff.Arjohuntleigh suggests to remind the staff involved of the device labeling, with special attention to correct lifting procedure.This is to be communicated to the customer.

• Brand Name: MAXI SKY 600
• Manufacturer (Section D): ARJOHUNT LEIGH MAGOG INC; 2001 tanguay st.; magog, quebec
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG, INC; 2001 tanguay st.; magog, quebec
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4820647
• MDR Text Key: 5898176
• Report Number: 9681684-2015-00023
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/03/2015,05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LD10319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2015
• Distributor Facility Aware Date: 05/08/2015
• Device Age: 3 NA
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2015
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: 59