MAUDE Adverse Event Report: UNKNOWN BED ENDS G-SERIES BED 9153653717; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Event Description

Consumer states the bed rail moves down so when she holds the rail to get out of bed it drops and this has caused her to fall on the floor several times.Consumer states during the falls she has hit her head on the fan by her bed, hit her head on the floor which is cement with carpet on it and could not remember the other injuries.Consumer states she did get medical attention for these injuries by going to the doctor.Consumer affairs called dealer who alleged she has fallen 4-6 times but does not have dates or times.No broken bones.Bruising and soreness alleged.The owner's manual of like product states that the bed rail is not an assist rail for getting into or out of bed.

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

• Brand Name: BED ENDS G-SERIES BED 9153653717
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4908985
• MDR Text Key: 6066791
• Report Number: 1525712-2015-03838
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/13/2015
• 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): Hospitalization