MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 600

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

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

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 04 october 2016 arjohunleigh received the customer complaint where it was reported that resident slid out of sling during transfer with ceiling lift maxi sky 600 and sling.As a consequences resident sustained a fractured knee.

Manufacturer Narrative

(b)(4).The attempts for a service tech to go on-site and perform evaluation have been taken.Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received, it appears most likely that during the resident's transfer in sling from the wheelchair to toilet using maxi sky 600 ceiling lift the resident dropped to the floor.When reviewing similar reportable events, we have found a number of cases with similar general fault description (slip out of sling).The trend observed for this failure mode is currently considered to be low.The maxi sky 600 ceiling lift and the sling device were inspected.No malfunctions regarding lift were found that could have caused or contributed to the event.Based on the information received from arjohuntleigh representative and photographic evidences we can state that sling was worn.This is an indication that the sling should have been withdrawn from use and replaced, and also indicates that the ifu was not being followed.Therefore, the sling and the lift which work together as a system were found to have not been to specification when the event took a place.It can be established that the system was being used for patient care when the event took place but it appears it contributed to the event possibly due to an use error.A drill-down analysis was conducted into this event.Based on our product knowledge and many simulations performed for many slings type there are few elements which could contribute to a person sliding out from the sling: - inadequate sling size used for transfer (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.- an obvious wrong application of the sling (e.G.Wrong type of the sling used).Also, in this case the body the person could slide out entirety as the shape of the sling would not support the body.- a sling loop detaching or not being attached to the lift device before starting the transfer.Comparing the possible scenarios described above to the event description it appears likely that the improper sling was used for resident.According to the maxi sky 600 current instruction for use (ifu): - "the spreader bar that is attached to the maxi sky 600 lift determines what sling can be used to transfer a patient".- "loop sling must be used with the 2-point spreader bar" - "the correct size sling will be able to support the patient's shoulders during the transferring procedure." please note that according to the sling ifu: "to use (hygienic) sling patient must have good upper body and head control plus sitting ability.The residents/patients arms are positioned outside the sling at all times." in summary: from our evaluation we find the cause of the reported event appears most likely to be related to 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.The training provided for the caregivers was found to be insufficient and in that fact all users must be trained as per ifu.Arjohuntleigh suggests to remind the staff involved of the device labelling, with special attention to the correct lifting procedure and all steps concerning choosing the sling for transfer.This is to be communicated to the customer.We found this complaint to be reportable to competent authorities.

Event Description

On (b)(6) 2016 arjohuntleigh received a customer complaint where it has been indicated that during the resident transfer in sling from the wheelchair to toilet using maxi sky 600 ceiling lift the resident dropped to the floor.As a consequences resident sustained a tibia fracture.

• Brand Name: MAXI SKY 600
• Type of Device: MAXI SKY 600
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki,, TX 62-05-2 ; PL 62-052 ; 2103170412
• MDR Report Key: 6069266
• MDR Text Key: 58845306
• Report Number: 9681684-2016-00052
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• 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: 02/10/2017
• Distributor Facility Aware Date: 10/04/2016
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/10/2017
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 86