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

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  malfunction  

Event Description

The customer reported that a patient fell out from a sling because the staff member had used an xl size sling as the l size was not available at the time.The sling being used was a standard 4 point padded sling with head support.The customer was not willing to provide additional information regarding the event.Customer stated that they had already done their own internal investigation and found that it was staff error in sling size selection.She confirmed to me there was no fault with the arjo product.

Manufacturer Narrative

Additional information will provided upon investigation conclusion.

Manufacturer Narrative

Additional information will provided upon investigation conclusion.

Manufacturer Narrative

The customer reported that during the transfer a patient fell out of the sling.During the interview, the customer indicated that the event occurred because the staff member used an incorrect size sling, and chose an xl size instead of the appropriate l size due to the unavailability of the latter at the time.No injury was reported.The customer stated that their internal investigation was conducted and found that it was a staff error in sling size selection.No fault was found with the sling.However, the customer declined to provide further details about the event circumstances.The arjo representative advised the customer how to select the proper size of the sling.Additionally, the customer informed that they plan to purchase additional slings to ensure they have a selection of slings available at all times.The instruction for use for passive clip sling contains information that: "the right type and size of slings should be used after proper assessment of each patient/resident's size, condition and the type| of lifting situation.If the patient/resident does not meet these criteria.An alternative equipment/system shall be used." due to the limited information provided to this complaint, we are unable to define the root cause of the reported patient fall.To sum up, the arjo sling was used during the patient transfer.The patient slip out of the device and in this regard, the lift and the sling which work as a system did not meet its performance specification.The complaint was decided to be reportable due to the information that the patient fell out from the device during transfer.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18362216
• MDR Text Key: 330940819
• Report Number: 9681684-2023-00086
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Female