MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-C1

Model Number HAMILTON-C1

Device Problem Defective Alarm (1014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

The report from hospital say: on (b)(6) 2022, the ventilator gave a technical defect alarm during pre-use inspection, showing alarm code "technical event: 285002".Hamilton-c1 made in jun.18, 2016.

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: no further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event while the ventilator was prepared for treatment.The root cause could not be determined as the customer hired a third-party maintenance company for repair but was not informed about the specific defect and the repair details.After repair the ventilator went back into service.The hospital was recommended to find a maintenance company authorized by hamilton for repair.There was no patient or user harm reported.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-C1
• 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: 18947707
• MDR Text Key: 338303775
• Report Number: 3001421318-2023-40741
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00730002856789
• UDI-Public: 0730002856789
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K181216
• 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: 03/20/2024

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 Model Number: HAMILTON-C1
• Device Catalogue Number: 161001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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