SORIN GROUP ITALIA S.R.L. - CRM FACILITY SPIDERVIEW; ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
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Model Number SPIDERVIEW |
Device Problems
Fluid/Blood Leak (1250); Overheating of Device (1437); Material Too Rigid or Stiff (1544)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/07/2021 |
Event Type
malfunction
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Event Description
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Reportedly, for at least two times with different battery brand (b)(6) and bovie batteries, both alkaline) the device overheated seriously in a way that it was almost impossible to touch.And one of the exam only lasted 18h and the slot of the battery was full of white substance released from the bovie battery (oxidation).With a third brand of battery (energizer), the overheating was not observed (or was at least not as noticeable).This recorder also does not memorize the date, it is difficult to have good impedances and any channel without noise.Hard buttons and color screen are also not appreciated.
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Manufacturer Narrative
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H6 - one device problem code has been added.E3: was filled (other health-care professional).Please refer to the analysis report.
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Event Description
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Reportedly, for at least two times with different battery brand (ikea and bovie batteries, both alkaline) the device overheated seriously in a way that it was almost impossible to touch.And one of the exam only lasted 18h and the slot of the battery was full of white substance released from the bovie battery (oxidation).With a third brand of battery (energizer), the overheating was not observed (or was at least not as noticeable).This recorder also does not memorize the date, it is difficult to have good impedances and any channel without noise.Hard buttons and color screen are also not appreciated.
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Search Alerts/Recalls
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