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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
Medical Device Problem Code Sharp Edges (4013)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed; 1 device had broken/damaged components, 1 device had missing components, and 1 device had bent components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 3 malfunction event(s), where it was reported the device had accessible 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
MDR Report Key9237966
Report Number0001831750-2019-01076
Device Sequence Number16628049
Product Code NZG
UDI-Device Identifier07613327261615
UDI-Public07613327261615
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized3
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/25/2019
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
Operator of Device No Information
Device Catalogue Number4402000001
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date10/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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