FDA Adverse Event
Malfunction
Summary report: N
STINGRAY DR
MDR report key: 756010
·
Received October 18, 2005
Report
- Report Number
- 1318879-2005-00001
- Event Type
- Malfunction
- Date Received
- October 18, 2005
- Date of Event
- August 24, 2005
- Report Date
- October 17, 2005
- Manufacturer
- INFIMED, INC.
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE HAVE YET TO DETERMINE THE ROOT CAUSE OF THIS DATABASE CORRUPTION, BUT IT SEEMS TO BE RELATED TO THE HOSPITAL'S PACS SYSTEM. WE HAVE CREATED A NEW SOFTWARE VERSION THAT SHOULD RESOLVE THIS INTERMITTENT PROBLEM (V1.3.2.17), AND THIS WILL BE INSTALLED AT SITES THAT MIGHT BE PRONE TO THIS UNIQUE SITUATION.
Description of Event or Problem · 1
THE PRODUCT'S COMPUTER DATABASE OF PATIENTS CAN BE CORRUPTED OCCASIONALLY WITH OTHER PATIENTS' IMAGE DATA. THIS ONLY OCCURS UNDER HIGH PATIENT THRU-PUT WHERE THEY ARE ATTEMPTING TOO MUCH MULTI-TASKING OF THE DIGITAL IMAGING SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STINGRAY DR | DIGITAL RADIOGRAPHIC IMAGING SYSTEM | LLZ | INFIMED, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |