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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
Model Number FL19H
Device Problems Break (1069); Mechanical Problem (1384); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2018
Event Type  malfunction  
Event Description
It was reported that the siderail drops quickly when lowered due to a damaged cable.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
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7367049
MDR Text Key103557429
Report Number0001831750-2018-00166
Device Sequence Number1
Product Code FMS
UDI-Device Identifier07613327169348
UDI-Public(01)07613327169348
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 03/23/2018
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 Model NumberFL19H
Device Catalogue NumberFL19H
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/23/2018
Initial Date FDA Received03/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2004
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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