Catalog Number CON-EQ-5000 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Burn(s) (1757)
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Event Type
malfunction
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Manufacturer Narrative
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Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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The customer reported that there was a malfunction with the hose on the equator® convective warmer that resulted in bodily injury (burn).Additional information was requested but no additional information was reported on degree of burn or if an intervention was needed.
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Manufacturer Narrative
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One device was received for investigation.The device was received without the hose or power supply.A review of the device history record, for the reported serial number, found that the device had been received in the past for repairs and was originally used as a demonstration device.Visual inspection found that the device and filter were in good condition.During functional testing, a known good hose and power cord were attached to the warming device and the unit was plugged in.The device performed its self-test with no issues observed.The device was set to each of its three different temperature settings; all temperatures were found within specification.The temperature was then measured while the device was 75% and 100% occluded; the device passed both tests.The warming device was forced into over and under temperature and at each temperature setting; the device passed all tests.During all three forced overheating simulations, the alarm sounded and the warming device shut itself off within temperature specifications.The device was then set to each of its three different temperature settings for an extended period of time; all temperatures remained within specification.As the returned device operated in specification, no evidence was found to suggest the reported event was related to an intrinsic product fault.(b)(4).
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Manufacturer Narrative
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Supplemental file #1 submitted under file mfr #: 2183502-2016-01655 was incorrect.No device was returned for investigation for the reported issue and therefore, no evaluation was able to be completed.As no evaluation was performed, the information submitted to the fda via the initial mdr remains complete.(b)(4).
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Search Alerts/Recalls
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