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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2023

Event Type  Death  

Event Description

Following information reported by the customer, the patient was found with remote cord of the maxi sky 2 ceiling lift around his neck.The patient allegedly committed self-harm resulting in death.No malfunction of the device was reported by the customer.The customer is conducting their own investigation.

• 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: 18569248
• MDR Text Key: 333545600
• Report Number: 1419652-2024-00007
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2024
• Distributor Facility Aware Date: 01/17/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male