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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-H900; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
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HAMILTON MEDICAL AG HAMILTON-H900; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Back to Search Results
Model Number 950004
Device Problems Overheating of Device (1437); Defective Component (2292)
Patient Problems Swelling (2091); Partial thickness (Second Degree) Burn (2694)
Event Date 06/02/2020
Event Type  malfunction  
Event Description
Infant was placed on a nasal cpap.Approximately five minutes later, the infant was found to be crying.The mask was removed and the skin in and around the mask was noted to be red and swollen.The cpap machine appeared to have a faulty heat display and did not shut off when overheating.The infant developed a second degree burn.The initial temp was noted to be 30.9 0c and was found to be 54.8 oc when the cpap was removed.Manufacturer response for cpap humidity heater, h900 (per site reporter).The company has indicated they can interrogate a memory card to investigate the issue.We have not seen a final report to date.
 
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Brand Name
HAMILTON-H900
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
HAMILTON MEDICAL AG
4655 aircenter cir
reno NV 89502
MDR Report Key10152705
MDR Text Key195100227
Report Number10152705
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number950004
Device Catalogue Number950004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2020
Event Location Hospital
Date Report to Manufacturer06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age1 DA
Patient Weight2
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