MATTRESS COVER FOR MEDICAL PURPOSES
Received Jul 27, 2011 · Event occurred Dec 31, 2007
Report 1525712-2011-00373 · MDR key 2180063
Device
Generic name
880.6190
Manufacturer
UnknownProduct problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Death
Narrative
Additional Manufacturer Narrative
(B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILE AN MDR WAS NEEDED. CONCLUSION - THE CONSUMER WAS A SMOKER. IN ADDITION, A TOXICOLOGY REPORT INDICATED THAT THE CONSUMER HAD A BLOOD ALCOHOL OF .263 AT THE TIME OF DEATH. UPDATE: (B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILE WAS PERFORMED. CONCLUSION - THE CONSUMER WAS A SMOKER. IN ADDITION, A TOXICOLOGY REPORT INDICATED THAT THE CONSUMER HAD A BLOOD ALCOHOL LEVEL OF .263 AT THE TIME OF THE DEATH. THE COUNTY FIRE MARSHALL STATED THAT A LIT CIGARETTE WAS THE CAUSE OF THE FIRE. THE MATTRESS MANUFACTURER AND THE AGE OF THE MATTRESS ARE UNKNOWN. THE FIRE MARSHALL CONCLUDED TWO POSSIBLE SCENARIOS: A LIT CIGARETTE CAUSED THE BED LINENS TO IGNITE, AND A LIT CIGARETTE CAUSE THE TRASH CAN NEXT TO THE BED TO CATCH FIRE IGNITING THE COMBUSTIBLE MATERIALS NEXT TO THE BED. NEITHER OF THESE SCENARIOS ARE SUGGESTIVE THAT AN INVACARE PRODUCT MALFUNCTIONED.
Additional Manufacturer Narrative
(B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILE AN MDR WAS NEEDED. CONCULSION - THE CONSUMER WAS A SMOKER. IN ADDITION, A TOXICOLOGY REPORT INDICATED THAT THE CONSUMER HAD A BLOOD ALCOHOL OF .263 AT THE TIME OF DEATH.
Description of Event or Problem
A CONSUMER DIED WHEN HE ALLEGEDLY FELL ASLEEP ON AN INVACARE BED WITH A LIT CIGARETTE.
Description of Event or Problem
A CONSUMER DIED WHEN HE ALLEGEDLY FELL ASLEEP ON AN INVACARE BED WITH A LIT CIGARETTE.