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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB STRETCHER; BED, PEDIATRIC OPEN HOSPITAL
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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB STRETCHER; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number 0190000000
Device Problems Break (1069); Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2017
Event Type  malfunction  
Event Description
It was alleged that the siderail cable is broken and the release handle was broken causing the siderail to be suck in the lowest position.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Upon completion of the device evaluation, it was identified that there was no issue with the siderail cable is broken and the release handle was broken causing the siderail to be suck in the lowest position.
 
Event Description
It was alleged that the siderail cable is broken and the release handle was broken causing the siderail to be suck in the lowest 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 STRETCHER
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 Key6541676
MDR Text Key74485109
Report Number0001831750-2017-00167
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 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0190000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2003
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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