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

Model Number HPL700

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Type  Death  

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.

Event Description

It was reported to the manufacturer, by the end user, per the end user, that facility called in stating that staff dropped a resident from a hpl700 and suffered broken bones, passing later.Facility mentioned that they purchased a hoyer presence cradle and installed it on the lift, which failed.Multiple attempts have happened to reach out to the customer to get more information on the details and the lift details, but no customer response.Complaint #1398218 was entered into our system.

• Brand Name: HOYER LIFTS
• 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: 18945891
• MDR Text Key: 338183998
• Report Number: 3009402404-2024-00009
• 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: Other
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HPL700
• Device Catalogue Number: HPL700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• 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): Other; Death; Hospitalization