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

Model Number HPL700

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report or other information submitted by (b)(6) healthcare under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by (b)(6) 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 the resident got hit on the head by one of the spreader bars so that facility was wondering if they make padding for them.Complaint #(b)(4) was entered into our system.

• 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: 18945887
• MDR Text Key: 338186112
• Report Number: 3009402404-2024-00010
• 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: 03/19/2024

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?: No
• Device Model Number: HPL700
• Device Catalogue Number: HPL700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• 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