Model Number HL-90 |
Device Problem
Failure to Power Up (1476)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/01/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the water pump would not turn on during testing.There was no patient involvement and no harm/adverse event reported.
|
|
Manufacturer Narrative
|
B3.Date of event: unknown.No information has been provided to date.D5.Other operator of device: operator of device is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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.
|
|
Manufacturer Narrative
|
D9: date returned to mfg.: 4/5/2024.H3 and h6 - updated one device was received for investigation.The devices quick connect was corroded, enclosure cracked under quick connect and the pole clamp is discolored.The device was functionally tested.The pump did start but did not stay on.The pump was replaced.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
|
|
Search Alerts/Recalls
|