MAUDE Adverse Event Report: INVACARE FLORIDA IVC BARIATRIC BED 9153641598

Model Number NA:BAR600IVC

Device Problem Inflation Problem (1310)

Patient Problem Death (1802)

Event Date 03/19/2017

Event Type  Death  

Manufacturer Narrative

Attempts to contact the supervisor at (b)(6) for more information were unsuccessful.Based on available information, it does not appear that the invacare bed or assist rail malfunctioned in anyway.It is unknown if the mattress was an invacare device.There is not enough information to determine if the mattress malfunctioned or performed as intended.If more information is received, the decision will be reevaluated.

Event Description

Invacare received a copy of a medwatch which was filed by (b)(6) which related the following information: while receiving personal care, the patient was turned on her side while pulling on the upper half side rail to assist.The lower half side rail was down.As she was turning the air mattress deflated, so that the patient's lower extremities slid out of the bottom side of the bed onto the floor.The aide went to the patient and helped her to slowly slid onto the floor; and went for help.She was transported to the hospital where she underwent examination and it was determined that she had bilateral fractures of the femur.She revoked the hospice benefit to receive aggressive therapy.When it was determined that she was not a candidate for surgery she was readmitted to the hospice benefit and transferred to the hospice inpatient unit.She died after being at the unit for three days.

Manufacturer Narrative

Additional information was received from (b)(6): the mattress on the bed was not an invacare mattress; it was a theraflo mattress by (b)(4).(b)(6) has inspected the bed and mattress per their procedure, and both were determined to be in good working order with no malfunction or defect.Vitas does not believe that the equipment had anything to do with the alleged incident; they believe that the patient's weight shifted when the air mattress deflated, causing her to slide down the bed.It is not anticipated that the bed will be returned to invacare for evaluation, as (b)(6) currently has the bed and the mattress quarantined per their procedure.The (b)(4) owner's manual states, "invacare products are specifically designed and manufactured for use in conjunction with invacare accessories.Accessories designed by other manufacturers have not been tested by invacare and are not recommended for use with invacare products.".

• Brand Name: IVC BARIATRIC BED 9153641598
• Type of Device: BARIATRIC BED
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6482062
• MDR Text Key: 72431436
• Report Number: 1031452-2017-00037
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NA:BAR600IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 137