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

Model Number	4402
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nurse found a pediatric patient lying on its side in a bassinet.The user facility stated the mattress appeared to have a divot in the middle, causing the patient to flip from their back to their side.As a result, the patient was found to have a slightly deformed head and was treated with a helmet.
Additional Manufacturer Narrative
The investigation has been completed and section h codes have been updated to reflect this.Upon communication with the user facility it was found that the device did not cause or contribute to an adverse event and section b5 has been updated to reflect this.
Event or Problem Description
It was reported that a nurse found a pediatric patient lying on its side in a bassinet.The user facility stated the mattress appeared to have a divot in the middle, causing the patient to flip from their back to their side.As a result, the patient was found to have a slightly deformed head and was treated with a helmet.Upon further investigation no defects were found with the devices and the user facility stated that pediatric patients can easily roll to their sides, no matter what surface they are on.The user facility also stated that pediatric patients are susceptible to head deformation; therefore, the user facility stated the product did not cause or contribute to this event and this is not a reportable issue.

• 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: 12295140
• Report Number: 0001831750-2021-01293
• Device Sequence Number: 14404546
• Product Code: NZG
• UDI-Device Identifier: 07613327261615
• UDI-Public: 07613327261615
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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?: Yes
• Operator of Device: No Information
• Device Model Number: 4402
• Device Catalogue Number: 4402000001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other