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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO NARA, DOMESTIC; BASSINET, HOSPITAL
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STRYKER MEDICAL-KALAMAZOO NARA, DOMESTIC; BASSINET, HOSPITAL Back to Search Results
Catalog Number 4402000001
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2018
Event Type  malfunction  
Event Description
It was reported the bassinet tub/basket could not lock into place, indicating a potential of the basket falling off.There was no reported patient involvement, medical intervention, or clinically significant delay in treatment as a result of this malfunction.
 
Manufacturer Narrative
It was clarified that there was no malfunction with this device.
 
Event Description
It was reported the bassinet tub/basket could not lock into place, indicating a potential of the basket falling off.There was no reported patient involvement, medical intervention, or clinically significant delay in treatment as a result of this malfunction.
 
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Brand Name
NARA, DOMESTIC
Type of Device
BASSINET, 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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7699810
MDR Text Key114685611
Report Number0001831750-2018-00770
Device Sequence Number1
Product Code NZG
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 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number4402000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? No
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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