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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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2016
Event Type  malfunction  
Manufacturer Narrative
The device was not evaluated by the manufacturer, as the user facility canceled their request for service and opted to perform their own repair.User facility canceled service request and performed own repair.
 
Event Description
It was reported via repair work order that the scale was 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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6136468
MDR Text Key61196167
Report Number0001831750-2016-00383
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
Report Date 04/25/2016
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
Initial Date Manufacturer Received 04/25/2016
Initial Date FDA Received11/30/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/22/2014
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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