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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE CORP. CECONOMY FOAM MATTRESS; GEO MATTRESS
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INVACARE CORP. CECONOMY FOAM MATTRESS; GEO MATTRESS Back to Search Results
Model Number 5180
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Physical Entrapment (2327); Aortic Dissection (2491)
Event Type  No Answer Provided  
Event Description
(b)(6) spouse reported that, at approximately 7:00 am on (b)(6) 2017, she entered the bedroom and found (b)(6) wedged between the hospital bed and the wall.Spouse called 911 and (b)(6) was pronounced dead at 7:44 am by the (b)(6) police department.(b)(6) was notified by the police officer at the scene.(b)(6) staff was immediately dispatched to the home.Specific information regarding the position of the body was not provided to (b)(6) staff by the official personnel on the scene.(b)(6) body was removed from the home by the (b)(6) medical examiner's office, where cause of death was determined to be "positional mechanical asphyxia due to entrapment confinement.".
 
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Brand Name
CECONOMY FOAM MATTRESS
Type of Device
GEO MATTRESS
Manufacturer (Section D)
INVACARE CORP.
elyria OH
MDR Report Key6377286
MDR Text Key69301633
Report Number6377286
Device Sequence Number1
Product Code FNJ
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 02/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number5180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/13/2017
Distributor Facility Aware Date02/06/2017
Event Location Home
Date Report to Manufacturer02/13/2017
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
ALTERNATING PRESSURE OVERLAY; CHAIR ALARM; HOSPITAL BED; OVER BED TABLE; TRANSPORT CHAIR
Patient Weight56
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