SUPERDIMENSION
Report
- Report Number
- 3004962788-2018-00022
- Event Type
- Injury
- Date Received
- May 11, 2018
- Date of Event
- April 19, 2018
- Report Date
- May 31, 2018
- Manufacturer
- COVIDIEN LP - SUPERDIMENSION INC
- Product Code
- JAK
- UDI-DI
- 10884521199989
- PMA / PMN Number
- K092365
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
A COMPONENT OF THE SUPERDIMENSION SYSTEM; CASE RECORDINGS, WERE RETURNED AND EVALUATED. THE EVALUATION RESULTED IN NO SYSTEM PROBLEM FOUND. ACCORDING TO ANALYSIS AN UNSUPPORTED IMAGE TYPE WAS USED FOR PLANNING: ORIGINAL\SECONDARY\AXIAL AND AIRWAYS ARE NOT PROPERLY VISIBLE ON CT (MAY BE CAUSED BY THE UNSUPPORTED IMAGE TYPE OR THE PATIENT BREATHING WHILE TAKING THE CT SCAN). IN ADDITION, THE CT CONTAINED UPPER BODY ANATOMY (VOCAL CORDS, THROAT AND MOUTH) AND IS NOT AN ENTIRE CHEST SCAN AS RECOMMENDED BY THE USER MANUAL. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A COMPONENT OF THE SUPERDIMENSION SYSTEM; CASE RECORDINGS, WERE REQUESTED BUT HAVE NOT YET BEEN RECEIVED. A REVIEW OF THE APPROPRIATE DEVICE HISTORY RECORDS OF THE SUPERDIMENSION CONSOLE INDICATES THIS DEVICE WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS. OUT OF AN ABUNDANCE OF CAUTION, SUPERDIMENSION IS FILING THIS MDR DUE TO THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ACCORDING TO THE REPORTER, THEY COULD NOT GET THE TWO LOWER PATIENT SENSOR TRIPLET'S (PST'S) WITHIN THE SENSING VOLUME AREA DUE TO THE SIZE OF THE PATIENT. THE PST'S WERE EITHER TOO HIGH OR TOO WIDELY SPREAD RELATIVE TO THE SENSING VOLUME AND REPOSITIONING WAS NOT ALLOWING THEM TO GET THE PST'S WITHIN THE SENSING VOLUME TO COMPLETE REGISTRATION. THERE WAS ONE STANDARD PAD BETWEEN THE BED AND PATIENT, WHICH WAS ABOUT 2" THICK. THE CASE WAS NOT COMPLETED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349389 | SUPERDIMENSION | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | COVIDIEN LP - SUPERDIMENSION INC | AAS00161-20 | 10884521199989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |