FDA Adverse Event
Malfunction
Summary report: N
DIGITAL DIAGNOST
MDR report key: 2211975
·
Received August 10, 2011
Report
- Report Number
- 3003768251-2011-00043
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Report Date
- May 20, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS GMBH DMC
- Product Code
- MQB
- PMA / PMN Number
- K982795
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION SHOWED THAT THE AUTOMATIC STITCHING PROCESS CAN LEAD TO AN INCORRECT IMAGE IF NOT ANALYZED CORRECTLY. IT WAS REPORTED THAT THE CUSTOMER WAS USING THE SYS INCORRECTLY AND AS A RESULT OF PT MOVEMENTS, PT BREATHING AND RULER MOVEMENT COULD LEAD TO AUTOMATIC STITCHING. BASED ON THIS REPORTED ISSUE THE CUSTOMER HAS BEEN RETRAINED ON HOW TO REVIEW THE INDIVIDUAL IMAGES AGAINST THE COMPOSITE IMAGE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A STITCHING PROBLEM, WHICH CAN POTENTIALLY LEAD TO A MISDIAGNOSIS. A CHILD WAS INVOLVED IN THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL DIAGNOST | MQB | PHILIPS MEDICAL SYSTEMS GMBH DMC | 712020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |