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

Model Number 5310IVC

Device Problem Hole In Material (1293)

Patient Problem Skin Tears (2516)

Event Type  No Answer Provided  

Event Description

Per end user's daughter, the springs are coming up through the mattress and cutting the end user.

• 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: 4101972
• MDR Text Key: 4721148
• Report Number: 1531186-2014-04292
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/19/2014,08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5310IVC
• 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: 09/19/2014
• Distributor Facility Aware Date: 08/29/2014
• Device Age: 15 MO
• Date Report to Manufacturer: 09/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other