MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-H900; HAMILTON-H900 HUMIDIFIER,

Catalog Number 950001

Device Problem Failure to Read Input Signal (1581)

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

Hamilton medical ag received the following event description from the distributor: right tube is not detected.It is not solved replacing the connectors.Control board does not work correctly.

Manufacturer Narrative

Control board was found defective and was replaced.

• Brand Name: HAMILTON-H900
• Type of Device: HAMILTON-H900 HUMIDIFIER,
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: ildem ustunkol ceylan ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 17036219
• MDR Text Key: 316280171
• Report Number: 3001421318-2023-02112
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K163283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 06/01/2023

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: Other
• Device Catalogue Number: 950001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/01/2023
• 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