Model Number HAMILTON-C3 |
Device Problems
Suction Problem (2170); Pressure Problem (3012); Device Handling Problem (3265)
|
Patient Problems
Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/24/2020 |
Event Type
Injury
|
Event Description
|
Ventilator alarmed with tf341009, tf346054, te 231036 and switched to safety mode 385002.
|
|
Manufacturer Narrative
|
The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems #2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites. detailed complaint and failure description: "therapist reported that after suctioning the patient the vent stopped giving the patient a breath.The vent was giving a yellow suctiong maneuver alarm.Multiple attempts to try to reset the vent.Still not giving pressure breath." several tfs and safety mode during ventilation.The safety mode will run for a specific period of time but if it is not recognized by the medical staff the ventilation will be insufficient for the patient.No harm to patient or user.The issue is not likely to be serious to public health but is likely to cause serious injury or death to patient or user.Furthermore is the issue not likely to be serious to public health but is likely to cause serious injury or death to patient or use if it were to recur.Therefore, the event has been deemed to be a reportable event.
|
|
Event Description
|
Therapist reported that after suctioning the patient the vent stopped giving the patient a breath.The vent was giving a yellow suction maneuver alarm.Multiple attempts to try to reset the vent.Still not giving pressure breath.Asked questions device type and serial number c3 sn (b)(6).Date of occurence (b)(6) 2020.Time of occurence 3:48 am.Issue with vent.Was the vent on a patient? yes.Was this event reported to the fda? no.Was there patient harm? was this unit bought from a third party vendor (not directly from hamilton)? no.When was the last pm/service of this device( may 2019)? 12/2019.Can biomed replicate problem? since it is a high risk unit, biomed is not allowed to evaluate the vent per policy.Steps biomed took to find/fix problems? since it is a high risk unit, biomed is not allowed to evaluate the vent per policy.
|
|
Manufacturer Narrative
|
The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems #2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites. a detailed investigation was performed by an expert from the technical service: this issue is deemed a reportable event since the malfunction "switch on safety mode due to tf 341009" can lead to a delay in the therapy since the ventilator cannot be used.Eventually a new ventilator needs to be prepared.The root cause of the switch on safety mode was determined to be an unintended use of the suctioning tool in conjunction with a closed suctioning system having as effect an incorrect interpretation of the situation.The correction in this case was to strictly follow the instruction for use.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event, while the medical device was used for treatment (in ventilation phase).There was no patient or user harm.The allegation in this complaint was confirmed to be a complaint.No further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event like this issue as it will be deemed a reportable event.
|
|
Search Alerts/Recalls
|