MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS BARIATRIC BED HEAD 9153641516

Model Number BAR600IVC

Device Problems Break (1069); Thermal Decomposition of Device (1071); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The dealer stated that they received a correspondence from the va stating: emergency: please assess/repair controls on hospital bed.Patient reports the wires burned up, causing the fire dept.To be called, and the bed will not work, is stuck with the head up , placing the patient in an awkward/dangerous position.

Manufacturer Narrative

This event is a duplicate of report number 1031452-2016-00625.It concerns bar5000ivc (head section) with serial number (b)(4), which is from the same bed (model bar600ivc) as bar5490ivc (foot section) with serial number (b)(4) referenced in 1031452-2016-00625.

Event Description

The dealer stated that they received a correspondence from the va stating: emergency: please assess/repair controls on hospital bed.Patient reports the wires burned up, causing the fire dept.To be called, and the bed will not work, is stuck with the head up , placing the patient in an awkward/dangerous position.

• Brand Name: BARIATRIC BED HEAD 9153641516
• 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: 5451563
• MDR Text Key: 39215195
• Report Number: 1031452-2016-00626
• Device Sequence Number: 1
• Product Code: OSI
• 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,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• 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