MAUDE Adverse Event Report: FUJIFILM CORPORATION ASPIRE CRISTALLE FDR MS-3500; FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number DR 3500 W 24X30 USA E

Device Problem Patient Data Problem (3197)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

Ref comp #(b)(4).

Event Description

On 4th march 2024, fujifilm healthcare americas corporation was informed of an event involving dr 3500 w 24x30 usa e.It was reported that the device is unable to separate cases in the mammo unit, it keeps mixing up the patient's information that do not match the correct patient.There is no patient harm or injury reported.There is no additional information provided.

• Brand Name: ASPIRE CRISTALLE FDR MS-3500
• Type of Device: FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 18983478
• MDR Text Key: 338665022
• Report Number: 1000513161-2024-00020
• Device Sequence Number: 1
• Product Code: MUE
• UDI-Device Identifier: 04547410297546
• UDI-Public: (01)04547410297546(11)200501
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024,03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR 3500 W 24X30 USA E
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1