MAUDE Adverse Event Report: JOERNS HEALTHCARE JOERNS ULTRACARE XT HOSPITAL BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number UCXTBED

Device Problem Break (1069)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/26/2018

Event Type  Injury  

Event Description

The pt fell from bed when the enabler bar broke.The clip holding the enabler bar, attached to the flat metal which was attached to the bed frame broke and the pt rolled out of bed resulting in a right femur fracture.

• Brand Name: JOERNS ULTRACARE XT HOSPITAL BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): JOERNS HEALTHCARE ; 5001 joerns dr; stevens point WI 54481
• MDR Report Key: 8273957
• MDR Text Key: 134072908
• Report Number: MW5083310
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UCXTBED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 118