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

Model Number HAMILTON-C3

Device Problems Suction Problem (2170); Pressure Problem (3012)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 06/10/2021

Event Type  malfunction  

Event Description

According to ventilation practitioner: patient was ventilated, o2 enrichment key was activated, nurse went to take care of a different patient, when returned: ventilator was in safety mode.

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.Hamilton fm 653570 rev.01 page 5 of 6 medical investigation report (remediation) confidential complaint nr: (b)(4).

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: andre sonnenberg ; via crusch 8; bonaduz, graubunden 7402 ; SZ 7402
• MDR Report Key: 18119956
• MDR Text Key: 328393275
• Report Number: 3001421318-2023-20047
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00730002856789
• UDI-Public: 0730002856789
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-C3
• Device Catalogue Number: 160005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2021
• 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