Model Number L1-CW-120V |
Device Problems
Insufficient Heating (1287); Temperature Problem (3022)
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Patient Problems
Chills (2191); Discomfort (2330)
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Event Type
malfunction
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Event Description
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It was reported that the new convective warmers are taking longer to warm patients compared to previous product.Units take at least 2-hours longer to warm patients.It was suggested adding a cotton sheet on top of the warming blanket.Staff tried this and there was no change/impact.This is reported to have lead to extended patient discomfort, longer wait-times, significantly decreased pacu's throughput, and may cause some surgeries to be cancelled due to delayed warming times.No report of patient death or serious injury.
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Manufacturer Narrative
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The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
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Manufacturer Narrative
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Manufacturing device history record review was not performed because manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.Should the product be returned or additional information be returned pertinent to the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Search Alerts/Recalls
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