FDA Adverse Event
Malfunction
Summary report: N
DIGITAL DIAGNOST
MDR report key: 2153449
·
Received June 21, 2011
Report
- Report Number
- 3003768251-2011-00040
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Report Date
- May 25, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS DMC GMBH
- Product Code
- MQB
- PMA / PMN Number
- K982795
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS CURRENTLY ONGOING AND CONCLUSIONS WILL BE SENT IN A FOLLOW UP REPORT TO THE FDA. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER STATED THAT: "THERE WAS AN ARTIFACT (VERY THIN, SHORT VERTICAL LINE) ON THE WALL DETECTOR IN THE SAME PLACE." HE WAS CONCERNED THAT THIS COULD POTENTIALLY LEAD TO A MISDIAGNOSIS. NO PATIENT WAS INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL DIAGNOST | MQB | PHILIPS MEDICAL SYSTEMS DMC GMBH | 712052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |