DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
Report
- Report Number
- 9616389-2014-00023
- Event Type
- Injury
- Date Received
- June 5, 2014
- Date of Event
- May 29, 2014
- Report Date
- June 30, 2014
- Manufacturer
- AGFA HEALTHCARE N.V.
- Product Code
- IZL
- PMA / PMN Number
- K103597
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
THE EVENT IN THIS REPORT OCCURRED ON (B)(6) 2014 AND THE INITIAL REPORTER PROVIDED INFORMATION ABOUT THE EVENT ON (B)(6) 2014. AGFA IS REPORTING THIS MDR EVENT TO THE FDA ON (B)(6) 2014. THE INITIAL REPORTER HAS NOT REPORTED THIS EVENT TO THE FDA, BUT HAS REPORTED THE EVENT TO HEALTH (B)(4). ON (B)(6) 2014, A MEDICAL RADIATION TECHNOLOGIST, AT THE (B)(6) SITE, WAS REQUESTED TO PERFORM A PORTABLE CHEST AND ABDOMEN X-RAY ON A (B)(6) MALE PATIENT. UPON ARRIVING AT THE (B)(6)'S BEDSIDE, THE TECHNOLOGIST USED PURELL HAND SANITIZER TO CLEAN HER HANDS. (THE CUSTOMER USES TWO TYPES OF PURELL: PURELL ADVANCED HAND RUB AND PURELL HAND SANITIZER.) SHE PROCEEDED TO SET THE DESIRED TECHNIQUE ON THE DX-D100 MOBILE UNIT CONSOLE OF 60 KVP @ 1.25 MAS (SMALL FOCUS/160 MA STATION/8MSEC). THE SITE'S STANDARD TECHNICAL FACTORS FOR A (B)(6) ARE 60 KVP @ 1.00MAS, (SMALL FOCUS/160 MA STATION/6MSEC) 1.27CGY.CM2. THE TECHNOLOGIST HAD TO PRESS THE ARROW ON THE CONSOLE TO MOVE THE MAS UP TO REACH 1.25 MAS. SHE IMMEDIATELY NOTICED THE MAS REACHED 6.4, SO SHE MOVED THE ARROW ON THE CONSOLE BACK DOWN TO 1.25 MAS. SHE THEN LOOKED A SECOND TIME AT THE CONSOLE SCREEN TO ENSURE THE TECHNIQUE, PROCEEDED TO GRAB THE EXPOSURE SWITCH AND THE LEAD SHIELDING AND MOVED TO THE PATIENT'S BEDSIDE. THE LEAD SHIELDING WAS USED FOR BOTH THE (B)(6) PATIENT AND THE TECHNOLOGIST. THE PATIENT DID RECEIVE GONADAL SHIELDING. AS WITH NORMAL PRACTICE WHEN HANDLING (B)(6) DURING EXAMS, THE TECHNOLOGIST POSITIONED AND HELD THE PATIENT AND MADE THE EXPOSURE. AFTER THE EXPOSURE WAS TAKEN, THE TECHNOLOGIST MOVED BACK TO THE CONSOLE AND NOTICED THE EXPOSURE INDEX WAS EXTREMELY HIGH AND THE DX-D100 UNIT HAD DISPLAYED A GENERATOR ERROR. THE IMAGE WAS OVEREXPOSED AS DETECTED DIRECTLY ON THE NX WORKSTATION. THE TECHNOLOGIST READ THE TECHNIQUE EXPOSURE FACTORS ON THE IMAGE AS 61KVP @ 203 MAS (LARGE FOCUS/320MA/.635 SEC) 170CGY.CM2. AT THAT TIME, THE IMAGE WAS NOT TRANSFERRED TO THE HOSPITAL'S PACS SYSTEM. THE TECHNOLOGIST THEN TURNED THE DX-D100 UNIT OFF AND USED ANOTHER MOBILE UNIT IN THE NEONATAL SUITE TO PERFORM THE REQUIRED RADIOGRAPH. THE DX-D100 MOBILE UNIT WAS TAKEN TO THE DIAGNOSTIC IMAGING DEPARTMENT AND NOT USED ON ANY OTHER PATIENTS. THE DX-D100 UNIT WAS TAKEN OUT OF OPERATION ON (B)(6) 2014 AND CURRENTLY IS STORED IN THE HOSPITAL'S BIOMED DEPARTMENT. AGFA SERVICE WAS AT THE CUSTOMER SITE ON (B)(4) 2014, INVESTIGATING THE EVENT AND COLLECTING ALL NECESSARY LOG FILES FOR REVIEW. THE SAME DAY, AGFA APPLICATIONS PERFORMED TESTING WITH ANOTHER DX-D100 AND REPRODUCED THE ERRATIC TECHNIQUE CHANGES WHEN A DROP OF LIQUID IS DROPPED ONTO THE TOUCHSCREEN. AGFA INVESTIGATION IS STILL UNDERWAY AND WILL REPORT ITS FINDINGS FOR ANY CORRECTIVE ACTIONS AND/OR RECOMMENDATIONS TO THE SITE, WHEN AVAILABLE. IN THE MEANTIME, AGFA IS IN PREPARATION OF A LETTER THAT WILL BE SENT TO INFORM CUSTOMERS WITH DX-D100 UNITS THAT WHEN LIQUID COMES IN CONTACT WITH THE DX-D100 TOUCH SCREEN, THE DEVICE MAY INCORRECTLY RECOGNIZE THIS AS USER INPUT ALTERING DEVICE SETTINGS. THE FOLLOWING SPECIFIC WARNING STATEMENT REFERENCED IN THE DX-D100 USER MANUAL WILL BE PROVIDED IN THE LETTER. WARNING STATEMENT: IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE THAT ALL THE EXPOSURE PARAMETERS ARE CORRECT BEFORE PERFORMING AN EXAM TO THE PATIENT, BY VERIFYING THAT THE PARAMETER SELECTION HAS NOT BEEN MODIFIED UNINTENTIONALLY OR BY THE CONTACT OF EXTERNAL ELEMENTS ON THE CONTROL CONSOLE, IN ORDER TO AVOID THE OVEREXPOSURE OR THE NEED OF PERFORMING A NEW EXAM TO THE PATIENT. ON (B)(6) 2014, AGFA SOLUTIONS MGR AND QARA REVIEWED AND DISCUSSED THE EVENT DETAILS DIRECTLY WITH THE CUSTOMER. THE CUSTOMER CONFIRMED THE TECHNOLOGIST INVOLVED WITH THIS EVENT HAD RECEIVED AGFA APPLICATIONS TRAINING ON THIS DX-D100 UNIT, WHICH WAS INSTALLED AND LIVE ON (B)(6) 2014. THE CUSTOMER EXPLAINED THEY HAD ONLY SEEN THIS TYPE OF BEHAVIOR WHEN A RESIDUE WAS LEFT ON THE CONSOLE SCREEN. IF A PERSON'S HANDS ARE WET OR STICKY, THEY DO NOT EXPERIENCE THE SAME BEHAVIOR. THE HOSPITAL HAS ELECTED TO NOT PLACE THE DX-D100 UNIT BACK INTO OPERATION, BUT TO PERFORM NON-CLINICAL TESTING WITHIN THEIR BIOMED DEPARTMENT. A THIRD PARTY CONSULTANT WILL BE INSPECTING THE DX-D100 UNIT ON (B)(4) 2014 AND THE SITE HAS CONFIRMED NO CHANGES WILL BE MADE TO THE DX-D100 UNIT. AGFA HAS REQUESTED THE SITE TO SHARE ANY REPORTS THEY OBTAIN FROM THE INSPECTION. SUPPLEMENTAL REPORT FOLLOW-UP WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.
AGFA IS REPORTING ADDITIONAL INFORMATION RELATED TO THE EVENT DESCRIBED IN THIS REPORT. THIS IS FOLLOW-UP #1 FOR 9616389-2014-00023. ON JUNE 6, 2014, AGFA REPORTED TO THE FDA AS REQUIRED BY 21 CFR PART 806.10 (SUBPART B), REPORTS OF CORRECTIONS AND REMOVALS, VIA 9616389-06-06-2014-001-C DESCRIBING THE EVENT IN THIS MDR AND THE INVESTIGATION UNDERWAY. URGENT FIELD SAFETY NOTICES WERE SENT TO BOTH US AND CANADIAN CONSIGNEES WHO HAVE INSTALLED EQUIPMENT DESCRIBED IN THIS EVENT. THE CUSTOMER IN THIS EVENT ALSO RECEIVED THE URGENT FIELD SAFETY NOTICE. ROOT CAUSE WAS COLLECTIVELY DETERMINED, BY AGFA AND THE SUPPLIER, TO BE DUE TO THE DROPS OF LIQUID THAT HAD FALLEN FROM THE HANDS OF THE USER, OVER THE MAS SELECTION ON THE TOUCH SCREEN, WHICH IN TURN MODIFIED THE SELECTED TECHNIQUE. ONCE THE TOUCH SCREEN IS CLEANED AND DRY, THE EQUIPMENT IS CONSIDERED SAFE, AS LONG AS THE USER AND CLEANING INSTRUCTIONS ARE FOLLOWED. AS PREVIOUSLY STATED, ALL CUSTOMERS HAVE BEEN SENT LETTERS DESCRIBING THE PROBLEM AND RECOMMENDED ACTIONS TO TAKE. THE CUSTOMER IN THIS EVENT REQUESTED A LETTER FROM AGFA STATING THEIR UNIT WAS SAFE AND EFFECTIVE, IN WHICH AGFA PROVIDED ON (B)(6) 2014. AS A PREVENTIVE ACTION, AN ADDENDUM FOR THE USER MANUAL WITH ADDITIONAL WARNINGS WILL BE ADDED TO EACH NEW UNIT DELIVERED TO AGFA BY THE SUPPLIER. THERE HAVE BEEN NO REPORTS BY ANY OTHER CUSTOMER FOR ISSUES RELATED TO THIS EVENT. ANY FURTHER CORRECTIVE ACTIONS FOR THIS EVENT WILL BE DOCUMENTED IN FDA 9616389-06-06-2014-001-C.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330146 | DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | DX-D 100 MOBILE WIRELESS | IZL | AGFA HEALTHCARE N.V. | DX-D100 MOBILE WIRELESS DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DA | Other |