MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS BARIATRIC BED FOOT 9153641517

Model Number BAR600IVC

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Provider states they smelled smoke in the patients home, they opened the window, another person in the house states they looked under the bed and it appeared the junction box had heat coming from it, no injury.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation, and subsequent testing verified the complaint.Per the expanded evaluation report, the issue was not able to be duplicated during testing.The bed did not produce any smoke, sparks, flames, or arcing while operating each of the motors individually or rapidly cycling multiple functions simultaneously.However, it was observed that there was evidence (deformation and discoloration) located on the control box housing and molex head motor connectors indicating that smoke and/or sparks had been produced by the control box at one time.The underlying cause is being/has been investigated through capa (b)(4) and recall crt16-0003.

Event Description

Provider states they smelled smoke in the patients home, they opened the window, another person in he house states they looked under the bed and it appeared the junction box had heat coming from it, no injury.

• Brand Name: BARIATRIC BED FOOT 9153641517
• Type of Device: BARIATRIC BED
• 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: 5604504
• MDR Text Key: 44222969
• Report Number: 1031452-2016-01710
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BAR600IVC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• 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