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

Model Number KMCLUN-D

Device Problem Device Handling Problem (3265)

Patient Problem Bruise/Contusion (1754)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

The arjo was informed about an event regarding maxi move passive floor lift and arjo clip sling (model no maa4000m-s).It was reported that during transfer a resident began to stiffen, lean back, and started to slide out backward from the sling.The nurse placed her hands in the resident's hip area to avoid the fall.The resident slipped out of the sling and sustained the head and lung contusion.Arjo service technician visited the customer facility after the event to perform a device inspection.No malfunction was found within the maxi move lift.The sling visual inspection showed that the sling label was no longer readable, no other sign of damage was found.Arjo slings with head support have two pockets at the head section, which contain plastics reinforcement pieces - stiffeners.The two plastic stiffeners are placed in the pockets of the sling to support patient head during the transfer.According to the customer statement the stiffeners were not used during the transfer.It was confirmed by the facility that after the sling was washed, the caregiver did not place the stiffeners on the sling.Moreover, the resident was diagnosed with a stage 4 pressure injury, that has aggravated during the transfer, and became sensitive.This caused the resident to become agitated, stiff, and to lean backwards in the sling.The passive sling clip instruction for use (ifu) instructs to: ¿check that the stiffeners are completely inside the stiffener pockets, if any.¿ ¿at any time, if the resident becomes agitated, stop transferring/transporting and safely lower the patient.¿ in the ifu, section ¿cleaning instructions¿ informs: ¿place the stiffeners back into the stiffener pockets, if any, before use¿ to sum up, the arjo floor lift and clip sling were used as a system for a patient transfer when the resident fell out of a device.The head stiffeners were missing and from that perspective, the system did not meet its performance specification.We decided to report this complaint to the competent authorities due to patient fall and serious injury occurrence.

Event Description

The arjo was informed about an event regarding maxi move passive floor lift and arjo clip sling (model no maa4000m-s).It was reported that during transfer a resident began to stiffen, lean back, and started to slide out backward from the sling.The nurse placed her hands in the resident's hip area to avoid the fall.The resident slipped out of the sling and sustained the head and lung contusion.

• Brand Name: MAXI MOVE
• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 12280405
• MDR Text Key: 265150842
• Report Number: 9681684-2021-00045
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KMCLUN-D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 60