Catalog Number 5C4474 |
Device Problem
Overheating of Device (1437)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/21/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a homechoice presented a burning odor during "warning" the solution before connection, and the patient stated that the heater plate was "too hot".The patient was not connected at the time of the event.There was no patient injury or medical intervention associated with this event.The homechoice was swapped out.No additional information is available.
|
|
Manufacturer Narrative
|
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.The event history log review was performed and did not find evidence related to the reported problem.The sample analysis was performed and there was no device malfunction found that could have caused or contributed to the reported problems.The reported issue was not verified.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|