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

Model Number MS010-00-00

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 03/10/2024

Event Type  Injury  

Event Description

Following the information reported, the event occurred during transfer of the resident using arjo maxi sky 2 ceiling lift and non arjo sling.During transfer from the bed to chair, the maxi sky 2 spreader bar tipped vertically and the sling¿s loop unhooked.This led to the resident¿s fall from the sling.The resident sustained head injuries requiring stitches.

Manufacturer Narrative

After the event, the arjo representative evaluated the device.The lift functional examination did not reveal any malfunction.The event was not recreated during device testing.It is not possible to determine how the spreader bar tipped vertically leading to unhooking the sling's loop and causing patient fall.The instructions for use dedicated to maxi sky 2 (001-15698-en rev.15) states: - "only use arjo slings with the maxi sky 2 series of ceiling lifts." arjo recommends the use of arjo patient lifts to be utilized with arjo branded slings in accordance with the devices¿ instructions for use.The customer did not follow the instruction for use and used not recommended sling for a transfer.To sum up, the arjo ceiling lift was used as a system with non arjo sling.No arjo device failure was observed during the device evaluation.The complaint decided to be reportable due to the resident's fall.

• Brand Name: MAXI SKY 2
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 19002423
• MDR Text Key: 338880819
• Report Number: 9681684-2024-00021
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 05055982771559
• UDI-Public: (01)05055982771559(11)230403
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS010-00-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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; Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 75 KG