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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; PEDIATRIC OPEN HOSPITAL BED
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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; PEDIATRIC OPEN HOSPITAL BED Back to Search Results
Catalog Number FL19F
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2014
Event Type  malfunction  
Event Description
It was reported by repair work order that one of the sockets and components that holds up the canopy were completely missing.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported by repair work order that one of the sockets and components that holds up the canopy were completely missing.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Upon completion of the investigation, it was confirmed that the missing socket would contribute to a cosmetic issue and the stretcher would still be functional with out this component.
 
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Brand Name
CUB PEDIATRIC CRIB- FIXED 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 Key3739432
MDR Text Key4224867
Report Number0001831750-2014-02875
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 03/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberFL19F
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/13/2014
Initial Date FDA Received04/10/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/09/2014
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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