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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE CARROLL CS SERIES BED
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INVACARE CARROLL CS SERIES BED Back to Search Results
Model Number IHCS7
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Fall (1848); Laceration(s) (1946)
Event Date 05/09/2016
Event Type  Death  
Event Description
My father had alzheimers and was a patient in a nursing facility.After going to bed at about 9pm on (b)(6), it appears he woke in his room at approx.10 pm and got out of bed.As he was in the room alone, we are uncertain what happened, but from the staff's comments it appears that he stood up from his bed, perhaps took a few steps, and fell backwards.When found, his head was under the bed with a severe laceration on the back-top of his scalp (requiring a dozen staples to repair) just under a heavy steel bracket used to secure the assist bar.The assist bars were not in use.The brackets have now been removed on all beds in the facility.Prior to his fall, my father walked unassisted, ate meals on his own and was in robust physical health for an (b)(6).His memory and speech, however, were not good following the fall.He lost nearly 25 lb in 55 days, never walked again, had to be fed, bathed, etc.By others and could barely sit up straight in the wheelchair he was then confined to.He died on (b)(6) 2016.
 
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Brand Name
CARROLL CS SERIES BED
Type of Device
CARROLL CS SERIES BED
Manufacturer (Section D)
INVACARE
MDR Report Key5839990
MDR Text Key51009371
Report NumberMW5063778
Device Sequence Number1
Product Code FNL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 07/28/2016
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 No Information
Device Model NumberIHCS7
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age86 YR
Patient Weight84
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