MAUDE Adverse Event Report: INVAMEX RELIANT 600 HD LOW BASE LIFT 9153640382; LIFT, PATIENT, AC-POWERED

Model Number NA:RPL600-1

Device Problem Separation Failure (2547)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/11/2022

Event Type  Injury  

Event Description

We received a medwatch 3500a from a facility regarding a 5-1/2-year old rpl600 lift.Two staff members were transferring the patient from the bed to the wheelchair when the bolt holding the harness on dislodged from the casing and came out.The patient then fell to the floor.The patient was taken to the emergency room for evaluation of neck and back pain.The was diagnosed with an l1 vertebral fracture and a closed head injury.

Manufacturer Narrative

Numerous attempts were made to obtain further details concerning the reported event and request the lift and sling be returned without success.It is unknown what medical treatment the patient received, maintenance history of the lift, training of the attendants in the use of the device and the type of sling that was being used with the lift.Based on the information available it is not possible to the cause of the incident.It is not clear what, if any malfunction occurred or if the cause was use error.Should additional information become available, a supplemental record will be filed.

• Brand Name: RELIANT 600 HD LOW BASE LIFT 9153640382
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; 102 parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa ; MX
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003666900
• MDR Report Key: 16270735
• MDR Text Key: 308444689
• Report Number: 9616091-2023-00003
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2022

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
• Device Operator: Health Professional
• Device Model Number: NA:RPL600-1
• Device Catalogue Number: RPL600-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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): Hospitalization
• Patient Sex: Male
• Patient Weight: 99 KG