MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS CS3 BED 9153651161; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number G5410IVC

Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104); Crack (1135); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dealer states the left part of the footspring where the headspring attaches is torn off.The head spring bent and cracked when left part of the footspring broke off.

• Brand Name: CS3 BED 9153651161
• 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: 5390155
• MDR Text Key: 36993210
• Report Number: 1031452-2016-00298
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G5410IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2016
• 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