MAUDE Adverse Event Report: INVACARE FLORIDA FULL-ELECTRIC 9153638225; VEHICLE, MOTORIZED 3-WHEELED

Model Number NA:5410IVC

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the junction box on a 5410ivc full electric bed stopped working and that black smoke starting coming from underneath the bed.Spoke to end users daughter and she stated the patient was in the bed at the time it started to smoke, but they unplugged it and it stopped smoking.No injury alleged.She is working with a service center but did not have the information with her.Should additional information should become available, this record will be updated accordingly.

Event Description

The alleged complaint states the junction box on a 5410ivc full electric bed stopped working and black smoke started coming from underneath the bed.

• Brand Name: FULL-ELECTRIC 9153638225
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6413168
• MDR Text Key: 70517443
• Report Number: 1031452-2017-00036
• Device Sequence Number: 1
• Product Code: INI
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:5410IVC
• Device Catalogue Number: 5410IVC
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2006
• 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