MAUDE Adverse Event Report: EZ WAY, INC 500LB SMART LIFT NO SCALE

Model Number	L500PN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Facility stated: 2 cnas were transferring resident from commode to bed.The upper right-hand loop by shoulder came off of hanger bar and resident fell to the floor.(b)(6) said the resident was a very top-heavy person.During the transfer, the resident crossed her hands and kept them to herself.She was riding in the sling as directed.Staff noticed a green cap came off the hanger bar.They said the green cap was on the hanger bar before the transfer.(b)(6) said they tried to re-enact the incident, but they don't know exactly how it happened.Maybe the resident's bottom brushed the bed or maybe the resident shifted her weight.Possibly sling was off slightly and wasn't positioned before moving the resident.(b)(6) also questioned if the sling was positioned too far up on resident's back the resident was life flighted to the hospital.Last known status is patient was in icu.No knowledge of any surgery as of 12:30pm on (b)(6) 2024.
Additional Manufacturer Narrative
Ez way tsm findings: did two in-service is one at 10:30 and one at 11 they're in total was about 40 some people that attended including one of the people that was there when the incident happened.After the in-service we talk to her she was very sad and did not have a clue how that strap came off.Plan of action in service and every time they lift someone, they are going to say time out when strap is tight before they left them in the air.Before i got there, they comped out a lot of people to make sure they were using the lift correctly before state surveyors got there.(b)(6) met.With the administrator (b)(6) and the (b)(6) and (b)(6) first to discuss questions and to try to re-enact the incident.They told me pretty much what they told (b)(6) about the incident.They did also go over with the state department of health the situation and could not figure out how this person fell out of the lift.They did have her hooked up with the straps, shoulder short, leg, green, lower the bed as far as they could, and she fell out of the sling.Not sure how the strap came off.The resident was moved out of the icu on (b)(6) 2024.Fractured sternum top of the bone.Hematoma of the pelvic region s37.892 a is the medical code.(b)(6) 2024- (b)(6) shared the resident was still in the hospital.The plan is for the resident to return to the nursing home in 1-3 days.

• Brand Name: 500LB SMART LIFT NO SCALE
• Common Device Name: LIFT
• Manufacturer (Section D): EZ WAY, INC; 710 east main street; clarinda IA 51632
• Manufacturer (Section G): EZ WAY, INC; 710 east main street; clarinda IA 51632
• Manufacturer Contact: amy scott ; 710 east main street; clarinda, IA 51632 ; 7125421814
• MDR Report Key: 19939277
• Report Number: 2183887-2024-00004
• Device Sequence Number: 7340241
• Product Code: FSA
• UDI-Device Identifier: 00848914000040
• UDI-Public: (01)00848914000040
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: L500PN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Female
• Patient Weight: 180 KG