MAUDE Adverse Event Report: LAND AMERICA HEALTH & FITNESS SEMI ELECTRIC FOOT SPRING 9153638202; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5310

Device Problems Bent (1059); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer is stating that the current hand pendant is shorted out, and the mattress springs are cracked and the springs are twisted as well as the bed rails are bent and cracked.No serial number dealer states the bed is a bed6 package from 2000 and that it is a semi electric bed.No other information provided.Additional non-reportable complaint for this device; dealer alleges the mattress springs are cracked and the springs are twisted.Additional non-reportable complaint for this device; dealer is alleging that the current hand pendant is shorted out.

• Brand Name: SEMI ELECTRIC FOOT SPRING 9153638202
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): LAND AMERICA HEALTH & FITNESS; 25 north 2nd rd; xiamen fujian province 3610 22; CH 361022
• MDR Report Key: 4469136
• MDR Text Key: 20459047
• Report Number: 1531186-2015-00690
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/29/2015,01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5310
• 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: 01/29/2015
• Distributor Facility Aware Date: 01/22/2015
• Device Age: 14 YR
• Date Report to Manufacturer: 01/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other