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

Model Number 5310IVC

Device Problem Product Quality Problem (1506)

Patient Problems Discomfort (2330); Injury (2348)

Event Type  No Answer Provided  

Event Description

Dealer stated that the mattress on a (b)(4) semi electric bed is lumpy, causing user to get pinched when getting into or out of the bed.Minor injury, no medical intervention sought.

• 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: 3944290
• MDR Text Key: 15182027
• Report Number: 1531186-2014-02600
• 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: 07/17/2014,06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Date Report Sent to FDA: 07/17/2014
• Distributor Facility Aware Date: 06/10/2014
• Device Age: 4 YR
• Date Report to Manufacturer: 07/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 73