MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS HEAD SECTION FULL ELECTRIC G-SERIES BED 9153653719; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number G5510

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Injury (2348); Skin Tears (2516)

Event Type  malfunction  

Event Description

Facility, (b)(6), stated that a caregiver reported that the end user fell from his (b)(4) full electric bed.The caregiver was cleaning the end user, rolled him over during this process but couldn't stop the user from rolling right off the bed.End users wife had to call the paramedics because the patient bruised his hip, and hit his head on the floor.

• Brand Name: HEAD SECTION FULL ELECTRIC G-SERIES BED 9153653719
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4472624
• MDR Text Key: 5326246
• Report Number: 1031452-2015-05392
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: G5510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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