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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER AND PAYKEL HEALTHCARE MR290; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
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FISHER AND PAYKEL HEALTHCARE MR290; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Back to Search Results
Lot Number 1207130304 0622 L4
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/25/2013
Event Type  No Answer Provided  
Event Description
White particulate matter was noted in humidifier canister.The humidifier canister, the sterile water bag and oscillator circuit was replaced with new supplies.The endotracheal tube remained in place.Five days later: debris floating in humidifier canister when removed.All equipment changed including, ventilator, medical air supply filter, humidifier canister, sterile- water for inhalation and ventilator circuit.Seven days later: particulate matter was found in humidifier canister.All new equipment replaced, changed from carefusion water to hospira water.No further growth.
 
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Brand Name
MR290
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
FISHER AND PAYKEL HEALTHCARE
15365 barranca parkway
irvine CA 92618
MDR Report Key3983006
MDR Text Key4753528
Report Number3983006
Device Sequence Number1
Product Code BTT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/18/2014
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received07/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? *
Device Operator Invalid Data
Device Lot Number1207130304 0622 L4
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/18/2014
Event Location Hospital
Date Report to Manufacturer08/06/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
YES: OSCILLATOR, ENDOTRACHEAL TUBE, OSCILLATOR; PERATURE PROBE.; CIRCUIT, STERILE WATER HUMIDIFIER CANISTER AND TEM; NO OTHER THERAPIES
Patient Age18 DAY
Patient Weight1
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