FDA Adverse Event
Malfunction
Summary report: N
DIGITAL DIAGNOST DUAL DETECTOR
MDR report key: 2455412
·
Received February 6, 2012
Report
- Report Number
- 3003768251-2012-00002
- Event Type
- Malfunction
- Date Received
- February 6, 2012
- Report Date
- January 10, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS DMC GMBH
- Product Code
- MQB
- PMA / PMN Number
- K982795
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE ENGINEER INVESTIGATION IDENTIFIED THAT THE PHYSICIAN WAS NOT USING THE SYSTEM CORRECTLY; THE AUTOMATIC STITCHING PROCESS CAN LEAD TO AN INCORRECT IMAGE DUE TO PATIENT MOVEMENTS, PATIENT BREATHING AND RULER MOVEMENT. AS PART OF THE AUTOMATED STITCHING WORKFLOW IT IS IMPORTANT THAT THE PHYSICIAN REVIEWS THE INDIVIDUAL IMAGES AGAINST THE COMPOSITE IMAGE. THE PHYSICIAN HAS BEEN RETRAINED. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED A STITCHING PROBLEM, WHICH CAN POTENTIALLY LEAD TO A MISDIAGNOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL DIAGNOST DUAL DETECTOR | MQB | PHILIPS MEDICAL SYSTEMS DMC GMBH | 712022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |