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

Model Number NA:RPL450-1

Device Problem Failure to Auto Stop (2938)

Patient Problem No Information (3190)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Invacare made repeated unsuccessful attempts to obtain information concerning an issue involving a rpl450-1 patient lift continuing to move upward on its own causing the user to sustain an injury that required hospitalization.The 10 year old device was manufactured by invamex and had an expected life of 8 years.The device is not being returned to invacare.Due to the allegation of an injury involving hospitalization, invacare is reporting the incident in an abundance of caution.

Event Description

A medwatch report was received from a nursing home stating ¿on (b)(6) 2020 hoyer lift with the serial number (b)(4) made byu invacare was being used to transfer a resident when the hoyer continued to move in an upward position on it's own without pressing on the remote.Patient did sustain an injury.".

• 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: 11021991
• MDR Text Key: 221847754
• Report Number: 9616091-2020-00025
• 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: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/23/2020

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:RPL450-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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: 77 YR
• Patient Weight: 64