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

Model Number BAR600IVC

Device Problems Burst Container or Vessel (1074); Smoking (1585); Extrusion (2934); Noise, Audible (3273)

Patient Problem Electric Shock (2554)

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

The foot section of the bed (which includes the foot and bed motors) and the hand pendant were returned for evaluation, however subsequent testing could not verify the complaint.Per the expanded evaluation report, there was no abnormal noise observed nor was there any spark or smoke present during the operation of the device.The "foot down," "foot up," "bed down," and "bed up" functions were able to operate without any complications.However, when the "head up" and "head down" functions were operated, there was no output from the motor.The underlying cause was identified as a damaged control box which exposed the k1 relay.Should additional information become available, a supplemental record will be filed.

Event Description

Per the tbm, the junction box completely blew apart.It was under a hospice patient at the time, and witnesses said when it went, it started smoking then sounded like a gun went off when it blew apart.When the carelinc driver arrived she started to diagnose what was wrong and received an electrical shock.No burns or lasting issues to the driver.

• 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: 5494459
• MDR Text Key: 40523709
• Report Number: 1031452-2016-00899
• 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: Replace
• Type of Report: Initial
• Report Date: 02/22/2016

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: BAR600IVC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/11/2016
• 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