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

Model Number 5310

Device Problems Bent (1059); Break (1069); Sticking (1597)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

End users son is stating that head tube is bent, will not raise and lower the head section of the bed.End users son is stating that the lanyard has broke and washer is broke.

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

• 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 44035 ; 8003336900
• MDR Report Key: 4891621
• MDR Text Key: 19981630
• Report Number: 1031452-2015-14666
• 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: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• 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
• Date Manufacturer Received: 06/09/2015
• 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