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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ARJOHUNTLEIGH BARIMAXX II; BED, AC-POWERED ADJUSTABLE HOSPITAL
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ARJOHUNTLEIGH, INC. ARJOHUNTLEIGH BARIMAXX II; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 60035
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Physical Entrapment (2327)
Event Date 10/27/2016
Event Type  Death  
Event Description
The patient was found unresponsive with his face down on the mattress with his torso between the side rails of the bed, with his left foot on the ground.He was last seen about 25 minutes prior and was centered in the middle of the bed.He is a right lower extremity amputee and was non-mobile prior to this incident.Once patient was found, he was lifted into bed and code proceeded but decision by family was to stop the code and not pursue heroic efforts.Autopsy was declined as the patient had a poor prognosis prior to the incident with multiple medical problems.
 
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Brand Name
ARJOHUNTLEIGH BARIMAXX II
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
ARJOHUNTLEIGH, INC.
45 barbour pond drive
us agent: dennis genito
wayne NJ 07470
MDR Report Key6084914
MDR Text Key59340547
Report Number6084914
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2016
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model Number60035
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2016
Event Location Hospital
Date Report to Manufacturer11/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Outcome(s) Death;
Patient Age68 YR
Patient Weight135
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