MAUDE Adverse Event Report: HANDI-MOVE HANDI MOVE 2510 CEILING MOTOR; PATIENT LIFT

Model Number HM2510

Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589); Connection Problem (2900)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/03/2016

Event Type  Injury  

Event Description

Caregiver transferred the patient into her shower chair, completely removed sling from patient, leaving no manufacturer accessories attached to patient.Caregiver then moved the motor laterally on the track away from the shower chair, hooking part of the lift onto shower chair and tipping over, causing patient to fall to floor and fracture leg.

• Brand Name: HANDI MOVE 2510 CEILING MOTOR
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): HANDI-MOVE; ten beukenboom 13; ninove, B-940 0; BE B-9400
• Manufacturer (Section G): HANDI-MOVE; ten beukenboom 13; ninove, B-940 0; BE B-9400
• Manufacturer Contact: paul pintelon ; ten beukenboom 13; ninove, B-940-0 ; BE B-9400 ; 3254319717
• MDR Report Key: 5754732
• MDR Text Key: 48332459
• Report Number: 3003063250-2016-00001
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Home Health Aide
• Device Model Number: HM2510
• Device Catalogue Number: 2510.0000.0004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2008
• Is the Device Single Use?: No
• 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 Age: 49 YR
• Patient Weight: 82