MAUDE Adverse Event Report: UNKNOWN AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS; 880.5100

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Event Description

Dealer reports our bed with another mattress on it, and unknown rails, patient is known to jump out of the bed.Dealer reports the end user fell and broke her femur.

• Brand Name: AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
• Type of Device: 880.5100
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4076433
• MDR Text Key: 15180366
• Report Number: 1525712-2014-05677
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/19/2014

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?: No
• 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: 08/19/2014
• Initial Date FDA Received: 09/10/2014
• 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): Required Intervention