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

Catalog Number 160005

Device Problems Suction Problem (2170); Pressure Problem (3012); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag comes to the conclusion: see cer (b)(4).

Event Description

The following was reported to hamilton medical ag: summary: during ventialtion, ventilator shows following failures: (b)(4).

Event Description

The following was reported to hamilton medical ag: summary: during ventialtion, ventilator shows following failures: 385002,231036,346054,341009.

Manufacturer Narrative

Hamilton medical ag comes to the conclusion: rootcause: 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 ef fect an incorrect interpretation of the situation.Correction: the correction in this case was to strictly follow the instruction for use and a software update.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-C3 VENTILATOR
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, switzerland 7402 ; CH 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• MDR Report Key: 17763070
• MDR Text Key: 323586882
• Report Number: 3001421318-2023-03200
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: 07630002801881
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1