|
Model Number HL-90 |
Device Problems
No Display/Image (1183); Display or Visual Feedback Problem (1184)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Other text: b3: date of event is unknown; no information has been provided to date.D3, g1, and g2 email is: (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
|
|
Event Description
|
It was reported that the display was not showing.The reported product fault occurred during testing and no patient or clinical injury.
|
|
Manufacturer Narrative
|
Evaluation codes: updated.Device evaluation: one device was received.A visual inspection found a broken front cover on the left side, the pcb was missing the lcd and the water tank was corroded with rust.During the functional testing, it was found that the lcd was missing off the pcb and the pump does not circulate.The cause of the issue was found to be damage to the pcb.No action was taken due to the condition of the device.It was deemed beyond economical repair and will be scrapped.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).
|
|
Search Alerts/Recalls
|
|
|