MAUDE Adverse Event Report: PRISM MEDICAL 475 LB CARE LIFT

Model Number 400001

Device Problems Break (1069); Inadequate Service (1564)

Patient Problem Pain (1994)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

The resident came to the facility on a gurney.The emts and the direct caregiver were attempting to transfer the resident from the gurney to the bed.She applied the transfer sling, hooked it to the lift, and began the transfer.The emts were at the resident's head and feet and the direct caregiver was operating the controls.The resident was lifted off the gurney and the direct caregiver was moving the lift towards the bed when the actuator (pn 452000) broke; the boom came down with the resident.The emts were able to prevent the resident's head from hitting the floor.The resident's back hit the lift legs and the floor.

Manufacturer Narrative

This actuator broke between the actuator shaft and base of the motor due to material wear (more than 8 years old).The owner's manual states "actuators are recommended to be replaced after four years of use." the customer removed this lift from service and purchased a new lift.The lift will not be returned for investigation, nor is it available for investigation.

• Brand Name: 475 LB CARE LIFT
• Type of Device: 475 LB CARE LIFT
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: jeff matthews ; 10888 metro ct.; maryland heights, MO 63043 ; 3146929135
• MDR Report Key: 4235537
• MDR Text Key: 20329347
• Report Number: 3007802293-2014-00025
• Device Sequence Number: 1
• Product Code: FSA
• 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,User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2001
• 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: 84 YR
• Patient Weight: 127