MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO NARA, DOMESTIC; BASSINET, HOSPITAL

Model Number	4402
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was evaluated in the field and the issue was confirmed; there was a bent component.The device was repaired and returned.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device had accessible sharp metal edges.There was no patient involvement.

• Brand Name: NARA, DOMESTIC
• Common Device Name: BASSINET, HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10310969
• Report Number: 0001831750-2020-00719
• Device Sequence Number: 16986798
• Product Code: NZG
• UDI-Device Identifier: 07613327261615
• UDI-Public: 07613327261615
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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 Model Number: 4402
• Device Catalogue Number: 4402000001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1