AUTOMATIC OVERBED TABLE OBT 200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for AUTOMATIC OVERBED TABLE OBT 200 manufactured by Joerns Healthcare.

Event Text Entries

[112723447] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7642109
• MDR Report Key: 7642109
• Date Received: 2018-06-22
• Date of Report: 2018-06-22
• Date of Event: 2018-03-24
• Date Facility Aware: 2018-03-24
• Report Date: 2018-06-22
• Date Reported to FDA: 2018-06-22
• Date Reported to Mfgr: 2018-04-19
• Date Added to Maude: 2018-06-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: AUTOMATIC OVERBED TABLE
• Generic Name: OVER THE BED TABLE
• Product Code: INW
• Date Received: 2018-06-22
• Model Number: OBT 200
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOERNS HEALTHCARE
• Manufacturer Address: 631 US 20 MICHIGAN CITY MI 46360 US 46360

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2018-06-22