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,health report with the FDA on 2019-11-14 for BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603 manufactured by Avanos Medical Inc..

Event Text Entries

[177234406] The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. All information reasonably known as of 13-nov-2019 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).
Patient Sequence No: 1, Text Type: N, H10


[177234407] Avanos medical, inc. Received a single report that referenced four different incidences, which were associated with separate units, involving four different events. This is the second of four reports. Refer to 3011270181-2019-00062 for the first event. Refer to 3011270181-2019-00064 for the third event. Refer to 3011270181-2019-00065 for the fourth event. It was reported the heat moisture exchange (mhe) was not fitting on the circuit with a tight fit. Additional information received 22-nov-2019 stated the event usually occurs between 2-hours and 6-hours during use. The vent alarm sounds when this occurs. The hme connection is simply reconnected to closed suction system (css) or changed out.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011270181-2019-00063
MDR Report Key9324399
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-14
Date of Report2019-11-14
Date Mfgr Received2019-10-18
Date Added to Maude2019-11-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 G1AB ULAX
Manufacturer StreetMERKURIUSGATAN 8 OSTERGOTLANDS LAN SE-05
Manufacturer CityMOTALA, SWEDEN 59132
Manufacturer CountrySW
Manufacturer Postal Code59132
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 Received2019-11-14
Model Number150
Catalog Number109381603
Lot Number2018-11-202019-04-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-11-14

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