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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 Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2016
Event Type  malfunction  
Event Description
It was reported that the siderail would not latch/lock in the upright position.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The customer declined to have device repaired at this time.
 
Event Description
It was reported that the siderail would not latch/lock in the upright position.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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key5676099
MDR Text Key45810865
Report Number0001831750-2016-00175
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 04/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2016
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
Date Manufacturer Received04/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2014
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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