MAUDE Adverse Event Report: TRIDIEN MEDICAL THERAFLO; LOW AIR-LOSS MATTRESS

Model Number 2001002

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 03/19/2017

Event Type  Death  

Event Description

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 on to the floor.The aide went to the patient and helped her to slowly slide on to 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.

• Brand Name: THERAFLO
• Type of Device: LOW AIR-LOSS MATTRESS
• Manufacturer (Section D): TRIDIEN MEDICAL
• MDR Report Key: 6512549
• MDR Text Key: 73479089
• Report Number: 6512549
• Device Sequence Number: 1
• Product Code: IOQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• 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: Health Professional
• Device Model Number: 2001002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2017
• Distributor Facility Aware Date: 03/19/2017
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BARIATRIC HOSPITAL BED; GERICHAIR.; O2 CONCENTRATOR
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 137