MAUDE Adverse Event Report: PRISIM MEDICAL PATIENT LIFT 625; 625 LIFT

Model Number C-625

Device Problems Unintended System Motion (1430); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2017

Event Type  Injury  

Event Description

The patient was being transferred from w/c to bed and the lifting tape malfunctioned and suddenly released causing the patient to rapidly descend towards the floor.The lift stopped (on its own) approximately 18 inches from ground and patient was assisted safely(by staff) to bed from w/c.The patient sustained no injuries and was discharged home.The lift was taken out of service (friday) and maintenance department has been investigating to determine the root cause.A call to manufacturer has been made requesting their assistance in problem solving.On-site visit has been scheduled for (b)(6) 2017.

• Brand Name: PATIENT LIFT 625
• Type of Device: 625 LIFT
• Manufacturer (Section D): PRISIM MEDICAL ; maryland heights MO 63043
• MDR Report Key: 6673019
• MDR Text Key: 78712513
• Report Number: MW5070665
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 68