MAUDE Adverse Event Report: LAND AMERICA HEALTH & FITNESS AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS; 880.5100

Model Number BAR600IVC

Device Problem Torn Material (3024)

Patient Problem Bruise/Contusion (1754)

Event Type  No Answer Provided  

Event Description

Consumer states that the seams were coming undone on the plastic cover on her mattress was coming apart and one day when the caretaker was changing her bed the plastic came completely off.Consumer states that now it is just foam that the consumer is just laying on foam.Consumer states that with her weight capacity and just the foam it makes her feel like she is laying on the bed frame.Consumer states she has pre existing medical conditions so she needs a mattress with good support so that she is not in pain from her pre existing medical conditions.No additional information provided.(b)(6) 2014, end user called back and advised did not mention at the time when originally called but have pressure bruises on both hip bones and both outside edges of the knee.(b)(4).

• Brand Name: AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
• Type of Device: 880.5100
• Manufacturer (Section D): LAND AMERICA HEALTH & FITNESS; 25 north 2nd rd; xiamen fujian province 3610 22; CH 361022
• MDR Report Key: 4070569
• MDR Text Key: 4740903
• Report Number: 1531186-2014-03924
• 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: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/06/2014,08/14/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BAR600IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2014
• Distributor Facility Aware Date: 08/14/2014
• Device Age: 28 MO
• Date Report to Manufacturer: 09/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 MO
• Patient Weight: 200