MAUDE Adverse Event Report: INVAMEX RELIANT 450 POWER LOW BASE LIFT 9153646735; LIFT, PATIENT, NON-AC-POWERED

Model Number	NA:RPL450-2
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Pneumocephalus (4587)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter stated the user was in an invacare patient lift and r114 invacare sling, following the proper care plan established by the facility.As the lift was being turned by a certified nursing assistant and another cna was next to the resident, the resident leaned to the left side and slipped out of the sling.The resident fell to the floor and sustained lacerations to the left forehead, forearm, and shin.The user received x-rays which indicated "air space around the brain" (pneumocephalus).The user is following up with the appropriate care team.
Additional Manufacturer Narrative
This incident is being reported in an abundance of caution due to the allegation of a possible serious injury.This patient lift was over 6 years old at the time of this issue and was manufactured by invacare invamex.The age of the sling couldn't be determined and has multiple manufacturing locations/suppliers.The pictures provided by the reporter appeared to show the sling and hanger bar were in proper working order.The allegation of the user leaning out of the sling and falling appears consistent with user error.The user was within the weight capacity of both of the patient lift (450 pounds) and the sling (450 pounds).The head laceration was treated with steri-strips.Air space around the brain is called pneumocephalus and refers to the presence of air or gas within the cranial cavity.The reporter indicated no further medical treatment was provided for any of the alleged injuries at this time.The exact underlying cause of the user falling out of sling during a transfer couldn¿t be definitively determined.
Additional Manufacturer Narrative
The invacare representative visited the facility and reviewed the device in question and interviewed facility staff.Based on the additional information it was confirmed that the patient lift and sling were in good working order with no signs of deterioration or malfunction.The facility staff clarified that the user reached through openings in the sling and lunged forward during the transfer process resulting in the user falling and sustaining injuries.Based on the available information the most likely underlying cause of this incident is user error.There is no indication of a malfunction with the patient lift or sling.
Event or Problem Description
The reporter stated the user was in an invacare patient lift and r114 invacare sling, following the proper care plan established by the facility.As the lift was being turned by a certified nursing assistant and another cna was next to the resident, the resident leaned to the left side and slipped out of the sling.The resident fell to the floor and sustained lacerations to the left forehead, forearm, and shin.The user received x-rays which indicated "air space around the brain" (pneumocephalus).The user is following up with the appropriate care team.

• Brand Name: RELIANT 450 POWER LOW BASE LIFT 9153646735
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22150048
• Report Number: 9616091-2025-00009
• Device Sequence Number: 8394196
• Product Code: FSA
• UDI-Device Identifier: 00841447102960
• UDI-Public: 00841447102960
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: NA:RPL450-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2018
• 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: Other
• Patient Sex: Unknown
• Patient Weight: 70 KG