Model Number CARDIOHELP |
Device Problems
Inaccurate Flow Rate (1249); Failure to Sense (1559)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/08/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A follow-up emdr will be submitted when additional information becomes available.A getinge technician will investigate the cardiohelp.
|
|
Event Description
|
It was reported that during treatment the flow/bubble sensor was not reading a flow and had constant bubble alarms.The cardiohelp was changed.No indication of actual or potential for harm or death was reported.Complaint number: (b)(4).
|
|
Event Description
|
Complaint number: (b)(4).
|
|
Manufacturer Narrative
|
It was reported that the flow/bubble sensor gives constant bubble alarms and the device is not reading a flow.Follow up information received on 2021-11-22 that the complaint#(b)(4) (reported under mfg report number 8010762-2021-00606) is a double entry to complaint complaint# (b)(4)(reported under mfg report number 8010762-2021-00598).Therefore, all investigation steps will be performed within the already reported complaint complaint# (b)(4) (reported under mfg report number 8010762-2021-00598).The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
|
|
Search Alerts/Recalls
|