Model Number W-601 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Blister (4537)
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Event Date 12/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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Retained samples of the concerned lot/batch of model sbt601 have been inspected visually.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.We will request further information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, details of the use and relay any in a follow up report.
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Event Description
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On (b)(6) 2023, we have been informed about 26 incidents with ecg electrodes.Monitoring ecg electrodes (model sbw601 and sbt601) had been used with bodyguardian mini+ and bodyguardian one devices.The initial reporter has attached for each patient an incident summary.In total, there were 26 reports covering a period from december 01st - 28th.No medical intervention was necessary for 25 incidents.For 1 incident a medical intervention was needed to treat the injury.The reportable event disclosed that the patient's skin was prepared using soap and water before applying the ecg electrodes.The patient experienced "redness, blisters, bleeding".The ecg electrodes have been removed "while bathing".It was also reported that the patient has worn ecg electrodes for 2 days and had changed them one time.No skin irritation was visible before applying the ecg electrodes.It was stated that a medical intervention was needed to treat the injury and that an ointment was prescribed.No further information was provided.
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Manufacturer Narrative
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Retained samples of the concerened lot/batch of model sbt601 have been inspected visually.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.We have requested for further information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, details of the use and have been informed that "no additional information (.)" was available and our distributor has "not received any additional news, comments, or reports (.)." we therefore consider the investigation and the report closed.
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Event Description
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On (b)(6) 2023, we have been informed about 26 incidents with ecg electrodes.Monitoring ecg electrodes (model sbw601 and sbt601) had been used with bodyguardian mini+ and bodyguardian one devices.The initial reporter has attached for each patient an incident summary.In total, there were 26 reports covering a period from december 01st - 28th.No medical intervention was necessary for 25 incidents.For 1 incident a medical intervention was needed to treat the injury.The reportable event disclosed that the patient's skin was prepered using soap and water before applying the ecg electrodes.The patient experienced "redness, blisters, bleeding".The ecg electrodes have been removed "while bathing".It was also reported that the patient has worn ecg electrodes for 2 days and had changed them one time.No skin irrititation was visible before applying the ecg electrodes.It was stated that a medical intervention was needed to treat the injury and that an ointment was prescribed.No further information was provided.
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Search Alerts/Recalls
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