MAUDE Adverse Event Report: JOERNS HEALTHCARE AUTOMATIC OVERBED TABLE; OVER THE BED TABLE

Model Number OBT 200

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 03/24/2018

Event Type  Death  

Event Description

Unwitnessed fall: pt reports she was holding the side rail of bed with her right hand sitting on the side of her bed eating breakfast.She started to slide and held onto the bedside table.The table slid down and the pt fell to the floor.She reported increased pain in her legs and an x-ray was taken while the pt was in the facility.Report showed right femur fracture.Reports were given to pt and family, and the decision was made for the pt to stay in the facility for the night and come up with a plan in the morning.On march 25, 2018 vitas was notified that the pt reported pain had gotten worse so the pt was taken to (b)(6) emergency dept for treatment.Hospital x-ray found bilateral femur fractures confirmed.Treatment plan was for both legs to be casted and sent back to the facility on (b)(6) 2018 on continuous care for pain and symptom management.Expired on (b)(6) 2018, at that time it was undetermined if the fall was related to her death or not.On june 22, 2018 - obtained further info from the medical examiner on the cause of death for this pt.Me ruled that cause of death was "accident due to femur fracture" on the death certificate.On june 22, 2018 f/u report #1 sent to mfr.

• Brand Name: AUTOMATIC OVERBED TABLE
• Type of Device: OVER THE BED TABLE
• Manufacturer (Section D): JOERNS HEALTHCARE; 631 us 20; michigan city MI 46360
• MDR Report Key: 7642109
• MDR Text Key: 112723447
• Report Number: 7642109
• Device Sequence Number: 1
• Product Code: INW
• 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: Other
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OBT 200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2018
• Distributor Facility Aware Date: 03/24/2018
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/19/2018
• 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): Death
• Patient Age: 95 YR
• Patient Weight: 48