MAUDE Adverse Event Report: LEONHARD LANG GMBH MINDRAY; MULTIFUNCTION DEFIBRILLATION ELECTRODE

Model Number MR60

Device Problem No Apparent Adverse Event (3189)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot number were inspected visually and tested electrically for the function.All electrodes were within limits, no failure could be detected.We also received a document showing 7 patient injuries (skin reddening).The pictures were indicated to have been made "direct after defibrillation" and 30 minutes after the defibrillation.It is unclear, if there is a contradiction as the questionnaire indicated the procedure to be cardioversion.The images show skin redness which we consider a normal and known side effect in using defibrillation electrodes.The ifu states accordingly as a note "reddening of skin is normal." in some cases skin irritation was also observed around "the ecg electrode".We will try to clarify the potential contradiction and will provide a follow-up report.

Event Description

On may 20th, 2019, we have been informed about 7 incidents with defibrillation electrode sets at (b)(6) hospital - (b)(6).Defibrillation electrode set (model mr60) and a mindray beneheart d3 defibrillator had been used.The complainant stated that "most of the patients who use mr60 suffer from skin redness and swelling".In a questionnaire the user stated that "multiple patients had red skin underneath electrode pads after cardioversion treatment in more than 50% of the cases." the incidents happened in the period "(b)(6)-(b)(6) 2019.The patients had been described "all body types, all different weight, male and female patients.(.) all patients came for an electro cardioversion.(.) patients are prepared for treatment.(.) when patient was sweating, skin was dried carefully with a towel.(.) hair on the skin is properly shaved.Pads are attached just before treatment.(.) pads are placed properly.(.) pads are placed front and back (.) first shock 150 joules.Skin damage was seen noticed." the duration of procedure was reported to be 5-10 minutes.The used energy for the first shock was 150 joule, shock 2 and 3: 200 joule.It was reported that "there where patients with bladders [blisters] the day after cardioversion".The injuries were described as red skin, 2nd degree burns at the area of the electrode.It was also described "in some cases i saw some irritation in the area around the pad, but then i also so [saw] some irritation of the area around the ecg electrode." in some case a medical salve was necessary to treat the injuries.In addition, a set of 7 sets of photos were provided showing skin reddening after defibrillation.The complainant further stated that the user complaints peaked during use of lot 181008-0979 and decreased to less than half during use of lot 190108-0972.

Event Description

On (b)(6)2019, we have been informed about 7 incidents with defibrillation electrode sets at (b)(6) hospital - (b)(6).Defibrillation electrode set (model mr60) and a mindray beneheart d3 defibrillator had been used.The complainant stated that "most of the patients who use mr60 suffer from skin redness and swelling".In a questionnaire the user stated that "multiple patients had red skin underneath electrode pads after cardioversion treatment in more than 50% of the cases." the incidents happened in the period "(b)(6)2019.The patients had been described "all body types, all different weight, male and female patients.(.) all patients came for an electro cardioversion.(.) patients are prepared for treatment.(.) when patient was sweating, skin was dried carefully with a towel.(.) hair on the skin is properly shaved.Pads are attached just before treatment.(.) pads are placed properly.(.) pads are placed front and back (.) first shock 150 joules.Skin damage was seen noticed." the duration of procedure was reported to be 5-10 minutes.The used energy for the first shock was 150 joule, shock 2 and 3: 200 joule.It was reported that "there where patients with bladders [blisters] the day after cardioversion".The injuries were described as red skin, 2nd degree burns at the area of the electrode.It was also described "in some cases i saw some irritation in the area around the pad, but then i also so [saw] some irritation of the area around the ecg electrode." in some case a medical salve was necessary to treat the injuries.In addition, a set of 7 sets of photos were provided showing skin reddening after defibrillation.The complainant further stated that the user complaints peaked during use of lot 181008-0979 und decreased to less than half during use of lot 190108-0972.

Manufacturer Narrative

Retained samples of the concerned lot numbers were inspected visually and tested electrically for the function.All electrodes were within limits, no failure could be detected.Based on these test results, no difference between the two lot numbers could be observed.We also received a document showing 7 patient injuries (skin reddening).The pictures were indicated to have been made "direct after defibrillation" and 30 minutes after the defibrillation.However, the complainant corrected this later to cardioversion (not defibrillation).The images show skin redness which we consider as normal and a known side effect in using defbrillation electrodes.The ifu states accordingly as a note: "reddening of skin is normal." in some cases skin irritation was also observed by the reporter (in the questionnaire) around "the ecg electrode".No further conclusion can be drawn as to what might have caused the difference in the number of redness within 2 different lot numbers.However we assume that reddness is a well known side effect and close the investigation.

• Brand Name: MINDRAY
• Type of Device: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 8703309
• MDR Text Key: 148155935
• Report Number: 8020045-2019-00014
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 190005531500291
• UDI-Public: (01)190005531500291
• Combination Product (y/n): N
• PMA/PMN Number: K142803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2021
• Device Model Number: MR60
• Device Lot Number: 181008-0979
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other