STABLE BASE
Report
- Report Number
- 8020045-2018-00026
- Event Type
- Injury
- Date Received
- December 18, 2018
- Report Date
- January 22, 2020
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- DRX
- UDI-DI
- 10861779000281
- PMA / PMN Number
- K023503
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
RETAINED SAMPLES OF THE 10 DIFFERENT LOT/BATCHES OF ITEM T-601 [DI PORTION: (01)10861779000281 ] (160225-0079, 170717-0166, 170807-0165, 170808-0166, 170811-0168, 170817-0169, 180216-0255, 180219-0256, 180221-0257, 180222-0258) AND 15 DIFFERENT LOT/BATCHES OF ITEM W-601 [DI PORTION: (01)10861779000274] (170923-0074, 170926-0075, 171003-0151, 171004-0152, 171025-0154, 171030-0155, 171102-0156, 180226-0251, 180228-0079, 180228-0252, 180301-0071, 180305-0072, 180305-0254, 180309-0255, 180312-0256) HAVE BEEN INSPECTED VISUALLY AND ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 4 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, AND HOW THE SKIN WAS PREPARED BEFORE APPLICATION OF THE ELECTRODES WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON EACH OF THE EVENTS. WE ALSO HAVE REQUESTED WHY THESE COMPLAINTS HAVE BEEN COLLECTED WITHOUT PROVIDING ANY INFORMATION TO US AND WHETHER THERE WERE ANY RECORDED SKIN REACTIONS BEFORE. A TABLE WITH PATIENT CALL NOTES WERE PROVIDED BUT NO ANSWERS TO OUR REQUESTS. NO FURTHER ANALYSIS WAS POSSIBLE REGARDING THE APPROPRIATENESS OF SKIN PREPARATION, THE GENERAL STATE OF THE PATIENT'S SKIN PRIOR TO ELECTRODE APPLICATION AND ANY MEDICATION TAKEN, WHICH MIGHT HAVE HAD A SKIN WEAKENING EFFECT. WE HAVE THEREFORE CONTINUED TO REQUEST FOR THIS INFORMATION, HOWEVER, WITH NO SUCCESS. ON JULY 08TH, WE RECEIVED THE STATEMENT THAT "THERE ARE NO OTHER UPDATES TO PROVIDE FOR THE PREVIOUS COMPLAINTS". NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CUSTOMERS PROBLEMS. AN ADDITIONAL COMPLAINT WAS RECEIVED ORIGINATING FROM THE SAME TIER-3 CUSTOMER ON (B)(6)2019, COVERING ANOTHER 26 INCIDENTS OF SIMILAR NATURE ORIGINATING FROM A PERIOD OF THREE MONTHS (NOVEMBER TO JANUARY). IT HAS BEEN REPORTED UNDER MDR 8020045-2019-00007. WE WILL CONTINUE OUR INVESTIGATION BUT WILL REPORT ANY FINDINGS ONLY AS FOLLOW-UPS TO MDR 8020045-2019-00007.
RETAINED SAMPLES OF THE 10 DIFFERENT LOT/BATCHES OF ITEM T-601 [DI PORTION: (01)10861779000281 ] (160225-0079, 170717-0166, 170807-0165, 170808-0166, 170811-0168, 170817-0169, 180216-0255, 180219-0256, 180221-0257, 180222-0258) AND 15 DIFFERENT LOT/BATCHES OF ITEM W-601 [DI PORTION: (01)10861779000274] (170923-0074, 170926-0075, 171003-0151, 171004-0152, 171025-0154, 171030-0155, 171102-0156, 180226-0251, 180228-0079, 180228-0252, 180301-0071, 180305-0072, 180305-0254, 180309-0255, 180312-0256) HAVE BEEN INSPECTED VISUALLY AND ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 4 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, AND HOW THE SKIN WAS PREPARED BEFORE APPLICATION OF THE ELECTRODES WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON EACH OF THE EVENTS. WE ALSO HAVE REQUESTED WHY THESE COMPLAINTS HAVE BEEN COLLECTED WITHOUT PROVIDING ANY INFORMATION TO US AND WHETHER THERE WERE ANY RECORDED SKIN REACTIONS BEFORE. A TABLE WITH PATIENT CALL NOTES WERE PROVIDED BUT NO ANSWERS TO OUR REQUESTS. NO FURTHER ANALYSIS WAS POSSIBLE REGARDING THE APPROPRIATENESS OF SKIN PREPARATION, THE GENERAL STATE OF THE PATIENT'S SKIN PRIOR TO ELECTRODE APPLICATION AND ANY MEDICATION TAKEN, WHICH MIGHT HAVE HAD A SKIN WEAKENING EFFECT. WE HAVE THEREFORE CONTINUED TO REQUEST FOR THIS INFORMATION, HOWEVER, WITH NO SUCCESS. ON JULY 08TH, WE RECEIVED THE STATEMENT THAT "THERE ARE NO OTHER UPDATES TO PROVIDE FOR THE PREVIOUS COMPLAINTS". AS NO FURTHER INFORMATION WAS AVAILABLE DESPITE REPEATED REQUESTS FOR THE ALREADY EXISTING INCIDENTS WE HAVE DESIGNED A NEW QUESTIONNAIRE TAYLORED TO THE CUSTOMER'S SPECIAL USE MODEL. WITH THE NEW QUESTIONAIRE, WE ARE CONFIDENT TO RECEIVE IMPROVED INFORMATION ON FUTURE INCIDENTS TO BE ABLE TO DETERMINE A ROOT CAUSE. HOWEVER AS NO FURTHER INFORMATION WAS MADE AVAILBE ON THE INCIDENTS COVERED IN THIS REPORT, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CUSTOMERS PROBLEMS. WE CONSIDER THE INVESTIGATION CLOSED AND WILL ONLY RESUME IT WHEN NEW CASES ARE REPORTED. WE WOULD COVER THEM UNDER A NEW MDR.
ON (B)(6)2018, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH A VERITY ECG MONITOR. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 63 ACCOUNTS FROM MAY 2018 TO EARLY NOVEMBER 2018. THE ABOVE SUMMARY REPORT REFERRED TO 63 SEPARATE CASES, WHICH OCCURED BETWEEN (B)(6)2018, INVOLVING A TOTAL OF 10 DIFFERENT LOT/BATCHES OF ITEM T-601 (50814) AND 15 DIFFERENT LOT/BATCHES OF ITEM W-601 (50809). (...) SOME PATIENTS DISCONTINUED USE TO AWAITING HEALING OR MORE INFORMATION FROM PHYSICIAN AND OTHERS WERE SENT ELECTRODES THAT ARE MORE SENSITIVE, IF POSSIBLE, TO TRY. THESE ELECTRODES WERE USED WITH OUR VERITE DEVICE." NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.
ON NOVEMBER 29TH, 2018, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH A VERITY ECG MONITOR. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 63 ACCOUNTS FROM (B)(6) 2018 TO EARLY (B)(6) 2018. THE ABOVE SUMMARY REPORT REFERRED TO 63 SEPARATE CASES, WHICH OCCURED BETWEEN 1 MAY - 8 NOV 2018, INVOLVING A TOTAL OF 10 DIFFERENT LOT/BATCHES OF ITEM T-601 (50814) AND 15 DIFFERENT LOT/BATCHES OF ITEM W-601 (50809). SOME PATIENTS DISCONTINUED USE TO AWAITING HEALING OR MORE INFORMATION FROM PHYSICIAN AND OTHERS WERE SENT ELECTRODES THAT ARE MORE SENSITIVE, IF POSSIBLE, TO TRY. THESE ELECTRODES WERE USED WITH OUR VERITE DEVICE." NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.
RETAINED SAMPLES OF THE 10 DIFFERENT LOT/BATCHES OF ITEM T-601 (B)(4) AND 15 DIFFERENT LOT/BATCHES OF ITEM W-601 (B)(4) HAVE BEEN INSPECTED VISUALLY AND ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 4 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, AND HOW THE SKIN WAS PREPARED BEFORE APPLICATION OF THE ELECTRODES WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON EACH OF THE EVENTS. WE ALSO HAVE REQUESTED WHY THESE COMPLAINTS HAVE BEEN COLLECTED SINCE MAY WITHOUT PROVIDING ANY INFORMATION TO US BEFORE NOVEMBER AND WHETHER THERE WERE ANY RECORDED SKIN REACTIONS BEFORE (B)(6) 2018. WE WILL FOLLOW UP ANY "ADDTITIONAL" INFORMATION IN A FOLLOW UP.
ON NOVEMBER 29TH, 2018, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH A VERITY ECG MONITOR. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 63 ACCOUNTS FROM (B)(6) 2018 TO EARLY (B)(6) 2018. THE ABOVE SUMMARY REPORT REFERRED TO 63 SEPARATE CASES, WHICH OCCURED BETWEEN (B)(6) - (B)(6) 2018, INVOLVING A TOTAL OF 10 DIFFERENT LOT/BATCHES OF ITEM T-601 (50814) AND 15 DIFFERENT LOT/BATCHES OF ITEM W-601 (50809). (...) SOME PATIENTS DISCONTINUED USE TO AWAITING HEALING OR MORE INFORMATION FROM PHYSICIAN AND OTHERS WERE SENT ELECTRODES THAT ARE MORE SENSITIVE, IF POSSIBLE, TO TRY. THESE ELECTRODES WERE USED WITH OUR VERITE DEVICE." NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1012349 | STABLE BASE | ECG ELECTRODE | DRX | LEONHARD LANG GMBH | T-601 | 180216-0255 | 10861779000281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |