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: DRIVE MEDICAL; HOSPITAL BED
  • 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
 

DRIVE MEDICAL; HOSPITAL BED Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 02/19/2016
Event Type  Death  
Event Description
Drive medical received a notice of incident which involved a hospital bed that drive medical imports and distributes.Based on the information provided, the incident was a fatal fire but it is unsure if it occurred within a hospice facility or the patient's home.According to the fire marshall's initial assessment, the cause of the fire was either smoking or electrical overload.Cigarettes were found in an ashtray next to the patient even though the door has a no smoking sign, and that the whole building is a smoke free building.In addition to the alleged drive medical bed, other medical devices including oxygen equipment, nebulizer, app and wheel chair were also found in the apartment at the time of incident.Further investigation will be conducted which will occur around april 21st.The fire scene will be preserved in the interim.Since little information has been provided to drive medical in regard to the patient and equipments involved in the incident, we are unable to identify the bed and its manufacturer.Further inspection will be conducted by our attorney.This report is based from the information provided by the dme provider, the fire marshall, and drive medical's attorney.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DRIVE MEDICAL
Type of Device
HOSPITAL BED
MDR Report Key5542497
MDR Text Key41694558
Report Number2438477-2016-00016
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Respiratory Therapist
Type of Report Initial
Report Date 04/01/2016,03/02/2016
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2016
Distributor Facility Aware Date03/02/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/01/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NEBULIZER
Patient Outcome(s) Death;
-
-