Model Number 23210 |
Device Problems
Loss of or Failure to Bond (1068); Sensing Intermittently (1558); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
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Event Description
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The customer reported the sensor glue was easily dissolved after only a few hours of use, also the cable protection was falling off quickly so that the wires were exposed and the measuring was partly interrupted.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: other text: the returned sensors were evaluated.Visual inspection found sliding neck tape at sensor end; causing exposed conductor jackets and shields.During continuity tests; no short or open was detected, and no intermittent short or open was detected when manipulated.The devices are functioning electrically as designed.The sensors were tested with a lab cable for 15 minutes continuously and no problem was found, able to obtain spo2 and pulse rate values throughout the entire 15 minutes of testing., corrected data: d4.Model # updated from "2330" to "23210", d4.Lot # updated from "2j388" to "a12j388".
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Event Description
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The customer reported the sensor glue was easily dissolved after only a few hours of use, also the cable protection was falling off quickly so that the wires were exposed and the measuring was partly interrupted.No patient impact or consequences were reported.
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Search Alerts/Recalls
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