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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 3002 MASTER BOMS; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO 3002 MASTER BOMS; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 3002000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Fall (1848); Hematoma (1884); Hemorrhage, Subdural (1894)
Event Date 05/12/2014
Event Type  Death  
Event Description
It was reported via repair work order that allegedly the bed alarm did not go off and patient fell from bed.Further it was alleged that the patient developed a subdural hematoma and later expired.Upon evaluation of the unit no failures were found and issue could not be duplicated.No defect was found.The user facility also indicated they were not certain whether or not the bed exit system had been engaged.
 
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Brand Name
3002 MASTER BOMS
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3854148
MDR Text Key15818507
Report Number0001831750-2014-03044
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 Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number3002000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/12/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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