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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEONHARD LANG GMBH STABLE BASE; ECG ELECTRODE
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LEONHARD LANG GMBH STABLE BASE; ECG ELECTRODE Back to Search Results
Model Number T-601
Device Problem Insufficient Information (3190)
Patient Problem Irritation (1941)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand Name
STABLE BASE
Type of Device
ECG ELECTRODE
Manufacturer (Section D)
LEONHARD LANG GMBH
archenweg 56
innsbruck, tirol 6020
AU  6020
MDR Report Key8173015
MDR Text Key130623057
Report Number8020045-2018-00026
Device Sequence Number1
Product Code DRX
UDI-Device Identifier10861779000281
UDI-Public(01)10861779000281
Combination Product (y/n)N
PMA/PMN Number
K023503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/16/2021
Device Model NumberT-601
Device Catalogue NumberSBT601
Device Lot Number180216-0255
Was Device Available for Evaluation? No
Date Manufacturer Received11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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