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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE CONTINUING CARE; FORMERLY CARROLL HEALTHCARE, INC CARROLL HEALTHCARE LINAK; ARROBED (HI-LOW BED)
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INVACARE CONTINUING CARE; FORMERLY CARROLL HEALTHCARE, INC CARROLL HEALTHCARE LINAK; ARROBED (HI-LOW BED) Back to Search Results
Model Number LA31-U192-00
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Hemorrhage, Intraventricular (1892); Injury (2348); Test Result (2695)
Event Date 01/31/2015
Event Type  Injury  
Event Description
Bed rail malfunction.Latches when pulled into up position but outward pressure causes it to disengage and fall into down position.Client fell from bed onto floor causing injury.Initial report was no serious injury.On (b)(6) 2015 follow up diagnostic/ct scans revealed non-displaced fracture of the right distal most clavicle, fractures to the right second, third, fourth and fifth ribs without major displacement, and comminuted undisplaced fracture of the right femoral head.Ct scan of head/brain also indicated small areas or hemorrhage in the ventricles, bilateral occipital horns, left temporal horn.Client sent to (b)(6) for eval/treatment.
 
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Brand Name
CARROLL HEALTHCARE LINAK
Type of Device
ARROBED (HI-LOW BED)
Manufacturer (Section D)
INVACARE CONTINUING CARE; FORMERLY CARROLL HEALTHCARE, INC
one invacare way
elyria OH 44035
MDR Report Key4580782
MDR Text Key5336224
Report Number4580782
Device Sequence Number1
Product Code FNL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLA31-U192-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/31/2015
Event Location Nursing Home
Date Report to Manufacturer02/18/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age74 YR
Patient Weight66
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