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

Model Number HM2510

Device Problems Device Handling Problem (3265); Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

The involved medical device was inspected by the local dealer.No product problem or malfunction of the device was found.Patient is no longer a good candidate to use the patient lift independent because of her muscular dystrophy has progressed through the years.This was discussed with the patient many times over the years with the local dealer.Patient wants to use the sytem further, but no longer independent.Patient will use a spreader bar and sling with the assistance of a caregiver.

Event Description

Patient was using a patient lift : overhead track patient lifting/transfer system with a rigid body support.Patient was transferring independently from her wheelchair to the toilet.While lowering from the toilet, the hand control slipped from her hand and she attempted to catch it.This caused her to lose her postural grip in the body support and she slipped through the cups onto the floor.

• Brand Name: HANDI-MOVE - 2510 CEILING MOTOR
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): HANDI-MOVE NV; ten beukeboom 13; ninove, B-940 0; BE B-9400
• Manufacturer (Section G): HANDI-MOVE NV; ten beukeboom 13; ninove, B-940 0; BE B-9400
• Manufacturer Contact: paul pintelon ; ten beukeboom 13; ninove, B-940-0 ; BE B-9400
• MDR Report Key: 15922478
• MDR Text Key: 304872029
• Report Number: 3003063250-2022-00001
• 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: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HM2510
• Device Catalogue Number: 2510.0000.0004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 79 KG