MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER SCALE

Model Number 59011A

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 04/22/2019

Event Type  Injury  

Event Description

Cradle was "frozen" and not rotating.Upon further inspection, noted pin was frayed and broken inside.As noted prior - similar failure occurred in facility on hoyer with scale on (b)(6) 2019 with device purchased in 2018.

• Brand Name: HOYER SCALE
• Type of Device: HOYER SCALE
• Manufacturer (Section D): JOERNS HEALTHCARE; arlington TX
• MDR Report Key: 8561680
• MDR Text Key: 143513580
• Report Number: 8561680
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 59011A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2019
• Distributor Facility Aware Date: 04/22/2019
• Device Age: 5 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention