MAUDE Adverse Event Report: FUJIFILM CORPORATION DRYPIX 7000; MEDICAL DRY LASER IMAGER

Model Number DRYPIX 7000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 03/01/2007

Event Type  Death  

Manufacturer Narrative

The initial reporter is the attorney firm.The device details such as serial number and manufacturing date are unknown.There was no fujifilm device malfunction reported relating to the patient death.If additional information becomes available, a supplemental report will be submitted.

Event Description

On (b)(6) 2018 fujifilm received an inquiry for the product specifications of drypix7000 fuji medical dry laser imager (a device that prints digital image data onto dedicated film).The inquiry was related to an alleged claim that a breast cancer patient was potentially overlooked for breast cancer in a breast cancer examination.The x-ray films used for mammography in the examinations (march 2005 and march 2007) had already been discarded and the hospital only had the data stored, therefore a request by the initial reporter was made to output the image data to x-ray films, which were submitted as evidence.The initial reporter is attempting to identify if the evidence provided (with an unspecified imager) is more accurate than the x-ray films used in the examinations (with the fuji imager).The inquiry does not mention any defects of the device; the initial reporter explained that there was no doubt about the device.This incident is being reported in an abundance of caution because there was a death.Additional information was requested, but no further information is available.Date of event is listed as (b)(6) 2007 since exact date of event was not provided.Date of patient death is unknown.

• Brand Name: DRYPIX 7000
• Type of Device: MEDICAL DRY LASER IMAGER
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: safety officer ; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 8048522
• MDR Text Key: 126503824
• Report Number: 3001722928-2018-00059
• Device Sequence Number: 1
• Product Code: LMC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: DRYPIX 7000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death