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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; BED, PEDIATRIC OPEN HOSPITAL
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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number FL19H
Device Problem Failure to Calibrate (2440)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2017
Event Type  malfunction  
Event Description
It was reported that the scale control board was found to not calibrate upon installation in the unit, which can cause the scale to be inaccurate.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Supplemental submitted to include udi.
 
Event Description
It was reported that the scale control board was found to not calibrate upon installation in the unit, which can cause the scale to be inaccurate.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
CUB PEDIATRIC CRIB- HYD BASE
Type of Device
BED, PEDIATRIC OPEN 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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7088758
MDR Text Key94382119
Report Number0001831750-2017-00546
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 03/26/2018
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 No Information
Device Catalogue NumberFL19H
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/09/2017
Initial Date FDA Received12/06/2017
Supplement Dates Manufacturer Received11/09/2017
Supplement Dates FDA Received03/26/2018
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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