MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 600; LIFT, PATIENT, NON-AC-POWERED

Model Number LD10001

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

Following information reported, the patient slipped out of the sling.As the consequence, the patient sustained pain.There was no maxi sky 600 ceiling lift or sling issue found during inspection.

Manufacturer Narrative

The investigation is ongoing.The results will be provided upon conclusions of the investigation.

Manufacturer Narrative

The lift and sling inspection revealed that they were in good condition.No failure of the ceiling lift and sling that could contribute to the patient slipping out of the sling was found.After several attempts to gather more information, the facility representative sent the report with information that the event was a consequence of facility staff error, however no details concerning event circumstances was provided.The customer did not explain how the patient fall occurred.Arjo device was used for a resident transfer when the event occurred and from that perspective, it played a role in the event.No sling and ceiling lift malfunction was found.The complaint decided to be reportable due to the patient slipping out of the sling.

• Brand Name: MAXI SKY 600
• 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: 18620852
• MDR Text Key: 334672137
• Report Number: 9681684-2024-00007
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LD10001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2009
• 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): Other