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

Model Number UNKNOWN

Device Problems Sticking (1597); Scratched Material (3020)

Patient Problems Eye Injury (1845); Fall (1848)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

Dealer stated that the end users parents think that the bed rails on an unknown bed are sharp and are afraid that they will puncture the mattress.The parents also alleged that the rails do not go up high enough, allegedly caused the user to fall out of the bed, possibly has a black eye.User is notorious for wanting to get out of his bed.

• 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: 4195434
• MDR Text Key: 4968078
• Report Number: 1525712-2014-07188
• 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: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• 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
• Date Manufacturer Received: 10/01/2014
• 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): Other