MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER LIFT; PATIENT LIFT

Model Number HPL700

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 02/03/2024

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that i need to report a serious accident that happened while using the joerns hoyer lift hpl700.On saturday 2/3/2024, my daughter fell from the sling and on to the floor and fractured her femur.She was hospitalized for 5 days and is in an indescrible amount of pain.The fall happened because the sling came off the hooks when she was moving around.It is inconceivable that there are not some sort of clips to secure the hook up of the sling, like many models do have.This is not the frst time this has happened.The past occurances have been when she was on her bed waiting to lift and the lack of gravity on the sling while in motion allowed the sling to fall off the bar.This is a major design flaw that needs to be addressed.I would appreciate if someone would call me to discuss this.It has caused my daughter and my family an extreme amount of stress and anguish.Complaint #(b)(4) was entered into our system.Multiple attempts were made to reach out for further information from customer, with no response.

Manufacturer Narrative

This report or other informtion submitted by joerns healthcare under 21 cfr part 803, and and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

• Brand Name: HOYER LIFT
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 18921452
• MDR Text Key: 337869707
• Report Number: 3009402404-2024-00008
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HPL700
• Device Catalogue Number: HPL700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female