MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS UNIVERSAL BED END, SET 9153638198; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5307IVC

Device Problems Device Slipped (1584); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

Consumers nurse states the brakes don't work and the bed rolls all around when caring for the patient.

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

Consumers nurse states the brakes don't work and the bed rolls all around when caring for the patient.

• Brand Name: UNIVERSAL BED END, SET 9153638198
• 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: 5663689
• MDR Text Key: 45502585
• Report Number: 1031452-2016-02105
• 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,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5307IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2011
• 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