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

Model Number 950004

Device Problem Excessive Heating (4030)

Patient Problem Burn, Thermal (2530)

Event Date 06/02/2020

Event Type  Injury  

Event Description

User reported infant was placed on device and "approximately" five minutes later the patient was found crying.It was reported that the device's temp display showed an initial reading of 30.9 and was found to be 54.8 when removed.

• Brand Name: HAMILTON-H900
• Type of Device: RESPIRATORY HUMIDIFIER
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, graubunden CH-74 02; SZ CH-7402
• MDR Report Key: 10232951
• MDR Text Key: 197578497
• Report Number: 2937708-2020-82545
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 07/01/2020,06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 950004
• Device Catalogue Number: 950004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2020
• Distributor Facility Aware Date: 06/03/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 2