MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-C3

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 05/04/2021

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.  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.

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.

Event Description

Dear sven according to the customer the unit stop ventelate with no reason.And alarmed with tf : 341009 , 346054 , 385002 , 231036.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, graubuenden 7402 ; SZ 7402
• Manufacturer Contact: nikolai sonnenberg ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 16596510
• MDR Text Key: 312312710
• Report Number: 3001421318-2023-00847
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: 07630002808590
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K201306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-C3
• Device Catalogue Number: 161005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention