Catalog Number 5C4471R |
Device Problem
Device Emits Odor (1425)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was received and is in the process of being evaluated.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 smell of smoke was coming from a homecoice device during dwell while the patient was connected.The technical service representative (tsr) explained to the patient how to swap out the device.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.
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Manufacturer Narrative
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Complaint no: (b)(4).The device was received in the product analysis lab (pal) for evaluation.Internal and external inspection was performed and no issues were noted.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet electrical performance specification requirements per rite testing.The rite functional test failed for being received inoperative due to no power.An inspection performed on the power supply revealed the fuse was blown.The reported issue of burnt odor was verified during pal analysis.The fuse was replaced, and a short simulated therapy was successfully performed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported smoke smell was caused by the blown power supply fuse.The power supply was replaced.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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