REUSE ELECTROCARDIGRAPHIC LEADS
Report
- Report Number
- 1051786-2022-00016
- Event Type
- Injury
- Date Received
- March 8, 2022
- Date of Event
- February 7, 2022
- Manufacturer
- INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
- Product Code
- MWI
- UDI-DI
- 00884838029729
- PMA / PMN Number
- K131382
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
A PHILIPS REMOTE CLINICAL SUPPORT ENGINEER (RCSE) SPOKE TO THE CUSTOMER, DIGICARE BIOMEDICAL TECHNOLOGY (DGT). DGT REQUESTED INFORMATION CONCERNING ELECTRODES THAT WERE USED DURING PROCEDURES WITH ANIMALS. THE RCSE CONFIRMED WITH DGT THAT THIS EVENT HAD OCCURRED AT A THIRD-PARTY FACILITY CALLED (B)(6). THIS EVENT WAS ASSOCIATED WITH AN INVIVO 989803176381, ADVANCED APPS ECG CABLE AND NOT WITH THE 865024, INTELLIVUE MP5 MONITOR, AS WAS ORIGINALLY REPORTED. THE RCSE CONFIRMED THAT (B)(6)WAS USING THE INVIVO QUADTRODE CV MRI ELECTRODE IN CONJUNCTION WITH THEIR DIGICARE LIFEWINDOW MODEL X MONITORS FOR VETERINARY MONITORING. DGT THEN RELATED THAT SEVERAL UNSPECIFIED COMPLAINTS HAD OCCURRED IN WHICH OTHER ANIMAL PATIENTS HAD BEEN BURNED WITH THE PHILIPS QUADTRODE ELECTRODES AND THIRD-PARTY BIOPACK ECG THREE-LEAD SETS. DGT THEN REQUESTED ASSISTANCE ON HOW TO PREVENT THESE TYPES OF ISSUES FROM HAPPENING IN THE FUTURE. ADDITIONAL INFORMATION WAS LATER REQUESTED FROM DGT BY THE PHILIPS COMPLAINT INVESTIGATOR SEEKING CLARIFICATION DETAILS ABOUT THESE OTHER UNRELATED EVENTS. DGT WAS NOT ABLE TO PROVIDE ANY ADDITIONAL DETAILS CONCERNING THESE EVENTS. DGT INDICATED THAT ON (B)(6) 2022, THEY HAD CONDUCTED AN INDEPENDENT INCIDENT EVALUATION WHICH CONFIRMED THAT ON (B)(6) 2022 A NINE-YEAR-OLD MALE CANINE, WEIGHING 4.08KGS PRESENTED TO (B)(6) FOR AN UNSPECIFIED PROCEDURE WHICH WAS CONDUCTED BY THE (B)(6) RADIOLOGY AND NEUROLOGY TEAM. DGT CONFIRMED THAT DURING THE SCHEDULED PROCEDURE ¿THE PATIENT RECEIVED BURNS ON THE LATERAL ASPECT OF CHEST UNDER THE RR ELECTRODE. ONE ELECTRODE AND ONE LEAD WERE BURNED/MELTED. THE CUSTOMER INVIVO QUATRODE WAS PLACED ON THE PATIENT WHICH HAS FOUR BUTTON ADAPTERS AND WHILE THIS WAS MR SAFE, IT IS NOT RECOMMEND FOR USE WITH THE LIFEWINDOW MONITOR AS IT ONLY HAS 3 ECG LEADS. THE QUATRODE WAS NOT EXPIRED AND WAS USED ONCE. THE EL CHECK MONITOR WAS NOT USED PRIOR TO SCAN TO ENSURE IMPEDANCE WAS LESS THAN 5 OHMS." IT WAS CONFIRMED IN THE DGT INCIDENT EVALUATION THAT THE PATIENT'S LEGS WERE NOT CROSSED, THAT THE ECG CABLES WERE NOT COILED OR CROSSED, THAT A THERMAL BARRIER WAS USED TO COVER THE PATIENT, AND THAT THE THERMAL BARRIER WAS LABELED AS MRI COMPATIBLE. THE DGT INCIDENT REPORT CONTINUED BY STATING THAT, "THE AREA WHERE THE ELECTRODES WERE PLACED AND THE ELECTRODES THEMSELVES SHOWED A LOT OF HAIR ON THEM, POSSIBLY INDICATING THE ELECTRODE MAY NOT HAVE BEEN IN FULL CONTACT WITH THE SKIN." DGT CONFIRMED THAT THE CONTACT AREA ON THE PATIENT WAS "CLIPPED AND CLEANED THE AREA,¿ AND HAD ¿APPLIED SSD OINTMENT, COVERED WITH A TELFA, AND THEN A STOCKINETTE.¿ THE STAFF AT (B)(6) THEN ¿TREATED THE PATIENT WITH A FENTANYL CRI OVERNIGHT IN PLACE OF A FENTANYL PATCH TO HELP WITH THE PAIN CONTROL ASSOCIATED WITH THE BURN." THE PATIENT WAS LATER EUTHANIZED ON (B)(6) 2022 DUE TO A PROGRESSIVE NEUROLOGICAL DISEASE AND QUALITY OF LIFE CONCERNS UNRELATED TO THE SKIN BURNS ASSOCIATED WITH THIS EVENT. DGT THEN RECOMMENDED THAT (B)(6) ¿ONLY USE MRI SAFE SINGLE ELECTRODES PROVIDED BY DIGICARE AND USE THE EL CHECK MONITOR PRIOR TO EVERY SCAN. ENSURE ECG LEADS DO NOT TOUCH THE PATIENT¿S SKIN AS THIS CAN CAUSE HEAT TO BUILD UP WHICH CAN LEAD TO BURNS UNDER THE ELECTRODES. ENSURE ELECTRODES ARE NOT EXPIRED AND NO AIR IS TRAPPED BETWEEN THE ELECTRODE AND SKIN. A THERMAL BARRIER SHOULD BE PLACED BETWEEN THE LEADS AND THE SKIN. SHAVE, CLEAN, AND DRY SKIN WELL PRIOR TO ATTACHING ELECTRODES. MAKE SURE THE ECG LEADS ARE IN A STRAIGHT LINE PERPENDICULAR TO THE MAGNET¿S AXIS AND NOT DIRECTLY IN THE FIELD OF INTEREST. DO NOT LOOP IN A CIRCLE, S OR U SHAPE AND DO NOT TWIST THE ELECTRODES. WE RECOMMEND PURCHASING AN MRI SAFE BLANKET AS MANY MATERIALS USED TO COVER PATIENTS MAY CONTAIN METAL FIBERS THAT ARE NOT SEEN OR LISTED ON THE LABEL. DO NOT ALLOW PATIENT¿S LEGS TO BE CROSSED. TECHNICIANS USING THE MONITOR FOR MRI SHOULD BE FULLY TRAINED, MADE AWARE OF RISKS AND GIVEN SAFETY HANDOUTS PROVIDED BY DIGICARE." DGT WAS ADVISED BY THE PHILIPS RCSE "THAT THE INVIVO QUADTRODE CV MRI ELECTRODES ARE DESIGNED TO BE USED WITH THE PHILIPS INVIVO PRODUCTS." THE RCSE THEN PROVIDED INFORMATION FROM THE INVIVO MANUAL DOCUMENTS WHICH STATE TO NEVER "USE ANY ECG PATIENT LEAD CABLES OTHER THAN INVIVO MRI ECG PATIENT LEAD CABLES. PATIENT LEAD CABLES WHICH BECOME INADVERTENTLY LOOPED DURING AN MRI EXAMINATION MAY ACT AS CONDUCTIVE LINES FOR RF INDUCED CURRENTS, RESULTING IN EXCESSIVE HEATING AND POSSIBLE BURNS. WHEN PATIENT LEAD CABLES OR OTHER CABLES FORM A CONDUCTIVE LOOP IN CONTACT WITH THE PATIENT'S TISSUE, MINOR TO SEVERE BURNING CAN RESULT." THE RCSE THEN CONFIRMED THAT DGT HAD NOT FOLLOWED UP OR PROVIDED ADDITIONAL DETAILS FOR THIS SAFETY CASE. ADDITIONAL INFORMATION LATER PROVIDED BY DGT TO THE PHILIPS COMPLAINT INVESTIGATOR CONFIRMED THAT THE PHILIPS QUADTRODE ELECTRODES AND THIRD-PARTY BIOPACK ECG THREE LEAD SETS WERE NOT COMPATIBLE AND THAT AN UNINTENDED USE ERROR MAY HAVE OCCURRED WHEN THE CUSTOMER USED A THIRD-PARTY BIOPAK ECG THREE LEAD SET IN CONJUNCTION WITH A PHILIPS QUADTRODE ELECTRODE, WHICH HAS FOUR TABS. FURTHERMORE, IMAGES WERE PROVIDED BY DGT TO PHILIPS THAT CONFIRMED THAT HAIR FROM THE PATIENT WAS PRESENT ON THE ADHESIVE OF THE PHILIPS QUADTRODE ELECTRODE, INDICATING THAT THE CONTACT AREA MAY NOT HAVE BEEN CLEAN, WHICH COULD HAVE CONTRIBUTED TO THE BURN SUFFERED BY THE PATIENT. AS A RESULT OF THIS INVESTIGATION, NO MALFUNCTION OF THE PHILIPS INVIVO ADVANCED APPS ECG CABLE WAS FOUND TO HAVE OCCURRED. WE WILL CONSIDER THAT DIGICARE BIOMEDICAL TECHNOLOGY RESOLVED THE ISSUE WITH THE INFORMATION PROVIDED. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.
THE CUSTOMER REPORTED THAT AN ANIMAL WAS BURNT WITH THE LEAD SET. IT WAS CLARIFIED THAT THE PATIENT IS AN ANIMAL WHERE THEY SUFFERED SOME BURNS ON THE SKIN.
THE CUSTOMER REPORTED THAT AN ANIMAL WAS BURNT WITH THE LEAD SET. IT WAS CLARIFIED THAT THE PATIENT IS AN ANIMAL WHERE THEY SUFFERED SOME BURNS ON THE SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1313691 | REUSE ELECTROCARDIGRAPHIC LEADS | REUSE ELECTROCARDIGRAPHIC LEADS | MWI | INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS | 989803176381 | 00884838029729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Male | Hospitalization |