MAUDE Adverse Event Report: INVAMEX POWER LIFT W/LOW BASE-PLUS 9153633519; LIFT, PATIENT, AC-POWERED

Model Number RPL450-1

Device Problem Detachment Of Device Component (1104)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The lift has not been returned for evaluation.The complaint could not be verified, and the underlying cause could not be determined.Based on the information provided, a device malfunction cannot be confirmed.The nursing home administrator stated that they did not notice if the locknut was loose prior to using the lift.The invacare reliant rpl450-1 user manual states, "after any adjustments, repair or service and before use, make sure all attaching hardware is tightened securely - otherwise injury or damage may occur." additionally, the maintenance safety inspection checklist states to inspect/adjust monthly the boom: check all hardware and hanger bar supports, and the hanger bar: check the bolt/hooks for wear or damage.A replacement lift has been sent to the nursing home.Should additional information become available, a supplemental record will be filed.

Event Description

The nursing home administrator stated that two assistants were transferring the patient from a bed to a chair when the locknut popped off the bolt that holds the hanger bar onto the boom assembly causing the hanger bar to fall off.The patient fell to the floor and sustained a broken nose and broken ribs.X-rays were performed and the patient was hospitalized; it is unknown for how long.

• Brand Name: POWER LIFT W/LOW BASE-PLUS 9153633519
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6413150
• MDR Text Key: 70240206
• Report Number: 9616091-2017-00002
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nursing Assistant
• Device Model Number: RPL450-1
• Device Catalogue Number: RPL450-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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 Age: 97 YR
• Patient Weight: 109