BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-03 for BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603 manufactured by Avanos Medical Inc..

Event Text Entries

[181735985] The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is in-progress. All information reasonably known as of 02-mar-2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc. Product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10


[181735986] Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events. This is the first of three reports. Refer to 3011270181-2020-00040 for the second event. Refer to 3011270181-2020-00041 for the third event. It was reported the heat and moisture exchanger attached to the end of the endotracheal tube (ett) and to the ventilator circuit disconnected during ventilation. There was no reported injury and the device was replaced.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011270181-2020-00039
MDR Report Key9779426
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2020-02-05
Date Mfgr Received2020-02-06
Date Added to Maude2020-03-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1TRINITY MEDICAL DEVICES INC.
Manufacturer Street1 PLUCKEMIN WAY
Manufacturer CityBEDMINSTER NJ 07921
Manufacturer CountryUS
Manufacturer Postal Code07921
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER
Generic NameVAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
Product CodeBYD
Date Received2020-03-03
Returned To Mfg2020-02-14
Model Number150
Catalog Number109381603
Lot Number2019-04-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-03

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