FDA Adverse Event
Malfunction
Summary report: N
SUPERDIMENSION INREACH SYSTEM
MDR report key: 3901888
·
Received May 8, 2014
Report
- Report Number
- 3004962788-2014-00030
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- April 8, 2014
- Report Date
- May 8, 2014
- Manufacturer
- SUPERDIMENSION INC.
- Product Code
- JAK
- PMA / PMN Number
- K092365
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SITE RETURNED PROCEDURE RECORDINGS FROM THE SYSTEM FOR EVALUATION. EVALUATION RESULTS IDENTIFIED A SOFTWARE ANOMALY AND THE FAILURE MODE FOR THE SOFTWARE ANOMALY IS ACCEPTABLE PER THE SUPERDIMENSION FMEA DOCUMENTATION. OUT OF AN ABUNDANCE OF CAUTION, SUPERDIMENSION IS FILING THIS MDR BECAUSE OF THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.
Description of Event or Problem · 1
SITE REPORTED THE SUPERDIMENSION ILOGIC SYSTEM MONITOR SCREEN WAS JUMPING AND THE PHYSICIAN CANCELED THE SUPERDIMENSION PORTION OF THE CASE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF PATIENT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279950 | SUPERDIMENSION INREACH SYSTEM | ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY | JAK | SUPERDIMENSION INC. | AAS00161-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |