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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; PEDIATRIC OPEN HOSPITAL BED
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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; PEDIATRIC OPEN HOSPITAL BED Back to Search Results
Catalog Number FL19H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fall (1848)
Event Date 08/22/2013
Event Type  malfunction  
Event Description
It was reported that the nurse placed the patient on the unit and locked the side rails in the upright position.It was reported when the nurse responded to the patient, they found the patient on the floor next to the unit.No adverse consequences or medical intervention were reported.
 
Event Description
It was reported that the nurse placed the patient on the unit and locked the side rails in the upright position.It was reported when the nurse responded to the patient, they found the patient on the floor next to the unit.No adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
The customer confirmed that there was no alleged malfunction with the unit.The customer also stated that the bio-medical engineer at the facility evaluated the unit and did not find a defect.The customer also refused an evaluation by the field service technician.
 
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Brand Name
CUB PEDIATRIC CRIB- HYD BASE
Type of Device
PEDIATRIC OPEN HOSPITAL BED
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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3730585
MDR Text Key4328274
Report Number0001831750-2014-02855
Device Sequence Number1
Product Code FMS
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,Followup
Report Date 03/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberFL19H
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/07/2014
Was Device Evaluated by Manufacturer? No
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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