Model Number FS-VM01 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Skin Inflammation/ Irritation (4545)
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Event Type
Injury
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Manufacturer Narrative
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Retained samples of the concerned lot number have been inspected visually and tested mechanically.Mechanical tests were performed on 3 retained samples of the claimed lot number.All tested samples were found to perform within limits.No faults could be detected.The involved device respectively samples of the claimed lot number have not been made available to us to the date of this report.We have requested further information on the patient, the skin preparation, if and how the skin injury had to be treated and will provide a follow up report upon receipt.
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Event Description
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On (b)(6) 2022, we have been informed about an incident involving ecg electrodes model fsvm01 at (b)(6).The initial report stated "a crew have recently reported an incident that has occurred due to removal of an ecg electrode causing skin damage to a patient.Although i have the lot number for this incident i have been made aware of similar incident without the recorded lot number, i am currently gathering the information so that i can pass this on to you.Lot number for this incident 220420-0383.I have passed on to the crew the relevance of safe storage of ecg electrodes, they assured me that the packaging was in date and only opened at the moment of placing the ecg electrodes." no further details have been disclosed so far.We have requested further information and we will follow up once we have received them.
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Manufacturer Narrative
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Retained samples of the concerned lot number have been inspected visually and tested mechanically.Mechanical tests were performed on 3 retained samples of the claimed lot number.All tested samples were found to perform within limits.No faults could be detected.The involved device respectively samples of the claimed lot number have not been made available to us to the date of this report.Despite repeated requests we have not received further information on the patient, the skin preparation, if and how the skin injury had to be treated at all.Therefore the incident is reported because it is unknown if and how the skin injury had to be treated.The incident might not constitute a reportable event.No conclusion can be drawn what might have caused the claimed incident.As no further information was made available, we consider the investigation closed.
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Event Description
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On june 14th, 2022 we have been informed about an incident involving ecg electrodes model fsvm01 at east midlands ambulance service nhs trust in the uk.The initial report stated "a crew have recently reported an incident that has occurred due to removal of an ecg electrode causing skin damage to a patient.(.) although i have the lot number for this incident i have been made aware of similar incident without the recorded lot number, i am currently gathering the information so that i can pass this on to you.Lot number for this incident (b)(4) i have passed on to the crew the relevance of safe storage of ecg electrodes, they assure me that the packaging was in date and only opened at the moment of placing the ecg electrodes." no further details have been disclosed so far.We have requested further information and we will follow up once we have received them.
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Search Alerts/Recalls
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