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

Model Number BAR600IVC

Device Problems Break (1069); Thermal Decomposition of Device (1071); Mechanical Problem (1384); 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

Additional/updated information was added to reflect the head and foot sections of the bed being returned to the manufacturer for evaluation, and subsequent testing verified the complaint.Per the expanded evaluation report, a spark or burning was not produced during the operation of the bed; however, there was discoloration and deformation on the control box, indicating that there had been a spark at capacitor c1 on the pcb.The control box housing had an indentation on the rear portion and there was damage near the connectors.The three motor connectors and pendant connector on the control box were discolored and there was deformation on the housing surrounding the connectors.Additionally, there was deformation and/or discoloration of the control pendant connector, all motor connectors, and the foot and bed motor connector strain reliefs, which was due to being in close proximity to the control box.All three motor housings (foot, bed, head) were in good condition.When the power cable was connected to a power supply and the pendant was used for all bed functions, there was no output from the three motors for either the up or down directions.However, when the motors and control pendant were connected to a test control box, each of the three motors were able to operate in both directions without complication.Therefore, the underlying cause of the spark near capacitor c1 of the pcb was due to a malfunction with the control box.Invacare is in the process of investigating the root cause of the malfunction.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.

• 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: 5451575
• MDR Text Key: 39215961
• Report Number: 1031452-2016-00625
• 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: 02/26/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• 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