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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; BED, PEDIATRIC OPEN HOSPITAL
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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number FL19F
Device Problem Insufficient Information (3190)
Patient Problems Swelling (2091); Physical Entrapment (2327)
Event Date 05/27/2017
Event Type  malfunction  
Event Description
It was alleged that the right arm of a patient became caught in between the bars of the siderail.It was alleged that the staff could not remove the patients arm as it was swelling.The fire department was called in to remove the arm from the siderail bars by spreading the bars open to remove the patients arm.The customer alleged that there was no issue with the product in terms of functionality, the patient just managed to slide their arm between the siderail bars and became stuck.No serious injury or adverse effects were reported as a result of the event.
 
Manufacturer Narrative
The customer alleged that there were no malfunctions with the product and reported that the patient managed to slide their arm between the rails and became stuck.The customer was advised the sideral pads were available for this device.
 
Event Description
It was alleged that the right arm of a patient became caught in between the bars of the siderail.It was alleged that the staff could not remove the patients arm as it was swelling.The fire department was called in to remove the arm from the siderail bars by spreading the bars open to remove the patients arm.The customer alleged that there was no issue with the product in terms of functionality, the patient just managed to slide their arm between the siderail bars and became stuck.No serious injury or adverse effects were reported as a result of the event.
 
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Brand Name
CUB PEDIATRIC CRIB- FIXED 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 Key6665034
MDR Text Key78456880
Report Number0001831750-2017-00268
Device Sequence Number1
Product Code FMS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue NumberFL19F
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/29/2017
Initial Date FDA Received06/23/2017
Supplement Dates Manufacturer Received05/29/2017
Supplement Dates FDA Received11/28/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/18/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age5 YR
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