Catalog Number 5C4471 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the homechoice machine was overheating the bag during use.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was not returned; therefore, a device analysis could not be completed.
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Manufacturer Narrative
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The device was received for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Internal and external inspection was performed and no issues were noted.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The homechoice device received functional and electrical testing of the device.The device was determined to meet functional and electrical performance specification requirements.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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