MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS SEMI ELECTRIC FOOT SPRING 9153638202; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5310IVC

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Bruise/Contusion (1754); Skin Tears (2516); Blood Loss (2597)

Event Type  malfunction  

Event Description

End user reported that the 5185 mattress on her (b)(4) semi electric bed has something, like little wires (not the springs) poking through, it is cutting her all over the place.User has cut her hand, it scratched her.She has also scratched her leg and it was bleeding.No medical attention sought.

• Brand Name: SEMI ELECTRIC FOOT SPRING 9153638202
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4390207
• MDR Text Key: 17263624
• Report Number: 1031452-2015-00345
• 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: Patient
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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
• Date Manufacturer Received: 01/05/2015
• 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
• Patient Weight: 127