MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-07 for DRYPIX 7000 N/A manufactured by Fujifilm Corporation.
[126504039]
The initial reporter is the attorney firm. The device details such as serial number and manufacturing date are unknown. There was no (b)(4) device malfunction reported relating to the patient death. If additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[126504040]
On (b)(6) 2018 (b)(4) received an inquiry for the product specifications of drypix7000 (b)(4)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 (b)(6) 2005 and (b)(6) 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 (b)(4) 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2443168-2018-00002 |
| MDR Report Key | 8048543 |
| Date Received | 2018-11-07 |
| Date of Report | 2018-11-07 |
| Date of Event | 2007-03-01 |
| Date Facility Aware | 2018-10-19 |
| Report Date | 2018-11-07 |
| Date Reported to Mfgr | 2018-11-07 |
| Date Added to Maude | 2018-11-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRYPIX 7000 |
| Generic Name | MEDICAL DRY LASER IMAGER |
| Product Code | LMC |
| Date Received | 2018-11-07 |
| Model Number | DRYPIX 7000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM CORPORATION |
| Manufacturer Address | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JA 258-8538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-11-07 |