MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-06-26 for SLDH, DIGITAL TOWER DSC002-03 SLDH-300P manufactured by Icad Inc..
[2983536]
We received notification from our customer that our secondlook, computer-aided detection (cad) system for mammography had allegedly malfunctioned. The customer reported that the icad system images were being sent to a (b)(4) workstation that appeared slightly skewed in the structured workstation report. The customer indicated that this event occurred after hologic upgraded their workstation software. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10260814]
Icad received information from the customer indicating that (b)(4) had identified that the problem was being caused by their device. Icad contacted (b)(4) for more information on this issue. Our investigation has identified the root cause of the reported condition as a software error used in the (b)(4) workstation that resulted in the skewed cad marks our customer reported to icad. On (b)(4) 2008, icad became aware of a class 3 recall on the (b)(4) full field digital mammography system. This system was identified by our customer as being used with the icad secondlook digital server in the (b)(6) 2008 reported event. Icad contacted (b)(4) to determine if the corrective actions identified in the (b)(4) recall notification had taken place. The (b)(4) representative indicated that the workstation serial numbers listed on the recall were being corrected. Icad made a follow-up phone call to our customer to check the status of the (b)(4) recall actions. Our customer reported that after (b)(4) corrected the reported software issue, the problem had not reoccurred. No additional actions are planned by icad however, we will continue to monitor for the reported condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225671-2008-00001 |
| MDR Report Key | 2853199 |
| Report Source | 06 |
| Date Received | 2008-06-26 |
| Date of Report | 2008-03-19 |
| Date of Event | 2008-03-01 |
| Date Mfgr Received | 2008-03-19 |
| Date Added to Maude | 2012-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE NAUGLE |
| Manufacturer Street | 98 SPIT BROOK RD. STE 100 |
| Manufacturer City | NASHUA NH 03062 |
| Manufacturer Country | US |
| Manufacturer Postal | 03062 |
| Manufacturer Phone | 6038825200 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1546-2008 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLDH, DIGITAL TOWER |
| Generic Name | SECONDLOOK DIGITAL CAD SYSTEM |
| Product Code | LMA |
| Date Received | 2008-06-26 |
| Model Number | DSC002-03 |
| Catalog Number | SLDH-300P |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICAD INC. |
| Manufacturer Address | 98 SPIT BROOK RD. STE 100 NASHUA NH 03062 US 03062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-26 |