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

Model Number 5410IVC

Device Problem Bent (1059)

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

The dealer stated that the frame is bent, he believed toward the left side.

Manufacturer Narrative

Product received expanded evaluation.The expanded evaluation report states: visual inspection- the head section was shifted and did not align with the lifting portion.Conclusions- utilizing existing complaint information and actual observations of the returned product in its "as received" condition, the complaint was confirmed for the bent head section frame.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product received expanded evaluation.The expanded evaluation report states: visual inspection- the head section was shifted and did not align with the lifting portion.Conclusions- utilizing existing complaint information and actual observations of the returned product in its "as received" condition, the complaint was confirmed for the bent head section frame.The dealer stated that the frame is bent, he believed toward the left side.

• 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: 5317575
• MDR Text Key: 34755738
• Report Number: 1031452-2015-17169
• 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,Followup
• Report Date: 01/08/2016

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: 5410IVC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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