Lot Number 4164928 |
Device Problem
Failure to Zero (1683)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/07/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that during incoming inspection without gas flow, 3 units of the 8133 hand of the gauge is out of place and not zero.
|
|
Manufacturer Narrative
|
Corrected data: product code and common device name were added.
|
|
Manufacturer Narrative
|
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The reported problem is a user perception from the pressure regulator pointer not resting at the stop pin at rest.The stop pin position does not represent a zero graduation on the scale of the pressure gauge and no problem was found.
|
|
Manufacturer Narrative
|
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-08383.The report was submitted in error.
|
|
Search Alerts/Recalls
|