Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIDIEN MEDICAL THERAFLO ; LOW AIR-LOSS MATTRESS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TRIDIEN MEDICAL THERAFLO ; LOW AIR-LOSS MATTRESS Back to Search Results
Model Number 2001002
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hip Fracture (2349)
Event Date 03/14/2017
Event Type  Death  
Event Description
Cna was providing personal care to patient.The mattress was inflated for personal care.A timer on the pump expired as the staff person was turning the patient on her left side.The mattress deflated and the patient fell out of the bed to the floor.The patient was transferred to the (b)(6) inpatient unit for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
THERAFLO
Type of Device
LOW AIR-LOSS MATTRESS
Manufacturer (Section D)
TRIDIEN MEDICAL
4200 nw 120 ave
coral springs FL 33065
MDR Report Key6512540
MDR Text Key73478982
Report Number6512540
Device Sequence Number1
Product Code FNM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/23/2017
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 Number2001002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/23/2017
Distributor Facility Aware Date03/14/2017
Device Age5 YR
Event Location Nursing Home
Date Report to Manufacturer03/23/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/23/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OXYGEN CONCENTRATOR.
Patient Outcome(s) Death;
Patient Age91 YR
Patient Weight87
-
-