MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-14 for DIAGNOST 56/66/76 9870-694-12172 NA manufactured by Philips Medical Systems.
[744991]
This report is being filed upon notification from our radiology manufacturer in another country, of an event that occurred. After implementation of a new digital spot film imaging (dsi) release, a customer complains about a mismatch of patient data and images during viewing and printout. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[8086587]
The root cause is a design problem in the d2ipb circuit board.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217116-2008-00006 |
| MDR Report Key | 980018 |
| Report Source | 05 |
| Date Received | 2008-01-14 |
| Date of Report | 2007-09-21 |
| Date of Event | 2007-09-18 |
| Date Mfgr Received | 2007-09-21 |
| Date Added to Maude | 2008-09-29 |
| 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 | DREW QUEEN |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY. |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4254877199 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | ROENTGENSTRASSE 24 |
| Manufacturer City | HAMBURG 2000 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 56/66/76 |
| Generic Name | IXL - (GENERAL PURPOSE R/F SYSTEM) |
| Product Code | IXL |
| Date Received | 2008-01-14 |
| Model Number | 9870-694-12172 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 982040 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-14 |