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

Model Number G5510

Device Problems Loose or Intermittent Connection (1371); Sticking (1597); Failure to Align (2522); Unintended Movement (3026); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4) beds are unsafe, side rails don¿t go up and down with the head section, rails are very high in the up position when bed at the lowest causing patient to climb over the rails.When rails released to lower they descend quickly, afraid of hands getting caught, the rails are taller than the bed standard mattress height at lowest point, and locking screws for head and foot section do not align.Side rail predrilled holes don¿t line up, bed ends rattle with any movement of bed, motor section not bolted securely.

• Brand Name: AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
• Type of Device: 880.5100
• 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: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3955325
• MDR Text Key: 17388411
• Report Number: 1031452-2014-04459
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G5510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2014
• 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