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

Catalog Number 160021

Device Problem No Display/Image (1183)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag comes to the conclusion: root cause: cable pn160357 defective correction: replacement of cable.

Event Description

The following was reported to hamilton medical ag: summary:blank display due to improperly connected display cable.

• 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: 19030722
• MDR Text Key: 339212475
• Report Number: 3001421318-2024-00823
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: 07630002800372
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201306
• 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
• Report Date: 04/03/2024

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 Catalogue Number: 160021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1