Catalog Number 050-12E |
Device Problems
Insufficient Heating (1287); Temperature Problem (3022)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/06/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).A device history record investigation did not show issues related to complaint.A record assessment was conducted and no changes required.The failure mode "not heating up" was unable to be confirmed with the picture submitted with the complaint form.The device has been returned, and the evaluation of said device is in progress at the time of this report.
|
|
Event Description
|
Customer complaint alleges that the device can't be heated prior to use.
|
|
Manufacturer Narrative
|
(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was performed; however, a current test could not be performed due to an open circuit.It is possible that the open circuit was due to overheating of the unit.Based on the investigation performed, the reported complaint was confirmed.All aquatherm heaters are 100% inspected during manufacturing; therefore, a defect of this type would be detected prior to release from the manufacturing facility.It was determined that operational context caused or contributed to the reported defect.
|
|
Event Description
|
Customer complaint alleges that the device can't be heated prior to use.
|
|
Search Alerts/Recalls
|