|
Catalog Number 81570 |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
|
|
Event Description
|
In this event it is reported that a 30k fsi-sli-1000 insert,pkd allegedly runs hot during use, no matter the amount of water.No injury occurred.
|
|
Manufacturer Narrative
|
Returned qty.1 insert, 81570, 22255-00083084, 24, bul test method / gp005-wi02 inductance: gauge id# (b)(6) due: 11/30/2024 result: 3.16 meets spec does not meet spec n/a tip condition: - meets spec does not meet spec n/a stack condition meets spec does not meet spec n/a tested on: g130 gage id# (b)(6) due date: 09/30/2023 set pressure: 35 psi water flow: output rate: 35 psi - meets spec does not meet spec n/a spray pattern: - meets spec does not meet spec n/a water leak: hp sealing ring proximal ring distal ring seam leak n/a vibration: - meets spec does not meet spec n/a grip condition: meets spec does not meet spec n/a other visual observation: insert is good, no fault found.Also insert was tested on a digital thermometer i.D.#(b)(6) due date: 09/30/2023.The temperature was 84.0° f, no fault found.The specification states are not to exceed 118.4°f.Alleged event: confirmed - not confirmed root cause: no defect (aft0140) no defect.Also insert was tested on a digital thermometer i.D.#(b)(6) due date: 09/30/2023.The temperature was 84.0° f, no fault found.The specification states are not to exceed 118.4°f.Conclusion code: no failure found.
|
|
Search Alerts/Recalls
|
|
|