FDA Adverse Event
Malfunction
Summary report: N
DIGITALDIAGNOST
MDR report key: 1912422
·
Received November 16, 2010
Report
- Report Number
- 3003768251-2010-00044
- Event Type
- Malfunction
- Date Received
- November 16, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 18, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MQB
- PMA / PMN Number
- K982795
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS CURRENTLY ONGOING AND CONCLUSIONS WILL BE SENT IN A F/U REPORT. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER ALLEGED, THAT THE "IMAGE QUALITY'' IS POOR ON SMALL PAEDIATRIC EXTREMITIES, BECAUSE THERE IS TOO MUCH NOISE AND IMAGES ARE NOT CLEAR ENOUGH TO SEE FINE BONY DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITALDIAGNOST | MQB | PHILIPS MEDICAL SYSTEMS | 712055 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |