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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
Model Number 4402
Medical Device Problem Code Sharp Edges (4013)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/01/2022
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the devices experienced sharp metal edges.There was no patient involvement.
 
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Brand Name
NARA, DOMESTIC
Common Device Name
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
brandon luckas
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key15113985
Report Number0001831750-2022-00871
Device Sequence Number6167932
Product Code NZG
UDI-Device Identifier07613327261615
UDI-Public07613327261615
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized2
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/27/2022
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 Model Number4402
Device Catalogue Number4402000001
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/01/2022
Initial Report FDA Received Date07/27/2022
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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