MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON C1; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number C1

Device Problem Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2020

Event Type  Injury  

Event Description

Rt manager reported vent alarm ventilation canceled and stopped working.He turned off unit and turned back on, went back to normal.Fda safety report id # (b)(4).

• Brand Name: HAMILTON C1
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): HAMILTON MEDICAL AG; bonadzu ; CH
• MDR Report Key: 10733299
• MDR Text Key: 213470648
• Report Number: MW5097443
• Device Sequence Number: 1
• Product Code: CBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention