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Model Number 153622 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the temperature display was unstable and sometimes disappeared after 28 days of use.Per follow up information received via ibc on (b)(6) 2022, it was clarified that temperature display was allegedly unstable and sometimes disappears.Per notification received from investigator on 01mar2023, it was reported that the during evaluation, the dimensions of the cable plug were found to be out of specifications.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Manufacturer Narrative
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The reported event is confirmed, supplier manufacturing related.Photo samples were submitted, however, could not be evaluated for the reported failure.The extension cable was returned without the original packaging.No damage to the cord was noted.Connections of the cord to the plug and socket were secure.Using a multimeter, the cord was tested for and found to have continuity.The cord was connected to an in-house temperature sensing catheter submerged in a water bath set to 37c.The cord was then attached to a kilo device and the temperature displayed erratically from no reading, and ranged from 30.1 c to 36.7 c.Though the temperature displayed erratically, the sample meets the specification "plug and jack must be firmly secured to wire." using a caliper the cable was measured and the tip and indentation diameters as well as the middle of indentation to mono jack measurements were found to be above specifications.As the out of specification measurements confirmed to not be a cause of erratic display.A potential root cause for this event could be operator error.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the temperature display was unstable and sometimes disappeared after 28 days of use.Per follow up information received via ibc on 05oct2022, it was clarified that temperature display was allegedly unstable and sometimes disappears.Per notification received from investigator on 01mar2023, it was reported that the during evaluation, the dimensions of the cable plug were found to be out of specifications.
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Search Alerts/Recalls
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