|
Model Number 9004051 |
Device Problem
Failure to Cycle (1142)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/12/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that a smiths medical capnograph has no wave and not responding to breaths (loud when tuned on).No patient involvement.
|
|
Manufacturer Narrative
|
Other, other text: h10: device evaluation: the reported complaint was verified after test the flow rate test on the returned device and there was a negative flow rate reading.Investigation determined that the tamper sticker seal was removed and the tubing connecting to the co2 pump were incorrectly routed, indicating the monitor was tampered with.The customer had gone into the device and connected the tube at the c02 pump at the wrong location that cause the complaint issue.The failure resulted from incorrect tubing routing by the user tampering with the monitor.Further dhr review is not relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.
|
|
Search Alerts/Recalls
|
|
|