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.

• 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
• MDR Report Key: 19002424
• MDR Text Key: 338880694
• Report Number: 1419652-2024-00029
• 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: Distributor
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2024
• Distributor Facility Aware Date: 03/11/2024
• Device Age: 11 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 75 KG